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“flott_RFCE_clean.docx”; 9/25; dl 10/10; lw to jf 10/12; names checked 10/12, jf to az 10/16; az to lw 10/16; lw to au 10/16; 1 Enhancing Safety Culture Through Improved Incident Reporting: A Case Study In Translational Research ABSTRACT The Imperial College Healthcare National Health Service Trust, a large health care provider in London, together with an academic research unit, used a learning health systems cycle of interventions. The goals were to improve patient safety incident reporting and learning and shape a more just organizational safety culture. Following a phase of feedback gathering from front-line staff, seven evidence-based interventions were implemented and evaluated from October 2016 to August 2018. Indicators of safety culture, incident reporting rates, and reported rates of harm to patients and “never events” (events that should not happen in medical practice) were continuously monitored. In this article we report on this initiative, including its early results. We observed improvement on some measures of safety culture and incident reporting rates. Staff members’ perceptions of six of the seven interventions were positive. The intervention exercise demonstrated the importance of health care policies in supporting local ownership of safety culture and encouraging the application of rigorous research standards. A mature safety culture has been found to be a common characteristic of high-performing health care organizations. 1 Safety culture is defined as “the product of individual and group values, attitudes, perceptions, competencies, and patterns of behaviour that determine the commitment to, and the style and proficiency of, an

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1

Enhancing Safety Culture

Through Improved Incident

Reporting: A Case Study

In Translational Research

ABSTRACT

The Imperial College Healthcare National Health Service Trust, a large health care

provider in London, together with an academic research unit, used a learning health

systems cycle of interventions. The goals were to improve patient safety incident

reporting and learning and shape a more just organizational safety culture. Following

a phase of feedback gathering from front-line staff, seven evidence-based

interventions were implemented and evaluated from October 2016 to August 2018.

Indicators of safety culture, incident reporting rates, and reported rates of harm to

patients and “never events” (events that should not happen in medical practice) were

continuously monitored. In this article we report on this initiative, including its early

results. We observed improvement on some measures of safety culture and incident

reporting rates. Staff members’ perceptions of six of the seven interventions were

positive. The intervention exercise demonstrated the importance of health care

policies in supporting local ownership of safety culture and encouraging the

application of rigorous research standards.

A mature safety culture has been found to be a common characteristic of

high-performing health care organizations.1 Safety culture is defined as “the product

of individual and group values, attitudes, perceptions, competencies, and patterns of

behaviour that determine the commitment to, and the style and proficiency of, an

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2

organization's health and safety management.”2 Beyond that definition, there is

increasing acknowledgment that a strong safety culture is one that adopts the

principles of a “just culture that abandons blame as a tool and promotes the belief

that incidents cannot simply be linked to the actions of the individual healthcare staff

involved but rather the system.”3

Given the complexity of organizational culture and the subjectivity of its

components, measuring it in a way that yields actionable data can be difficult.4

However, aspects of culture can be detected via staff engagement surveys, as the

relationship between staff engagement and the delivery of high-quality services has

been extensively corroborated.5,6 Furthermore, safe systems are typically

characterized by high rates of reporting of patient safety incidents and near misses.7

Evidence from health systems around the world focuses on three barriers to incident

reporting: time-consuming and cumbersome reporting systems, insufficient feedback

provided to reporters, and fear that reporting will result in blame8,9 (see the online

appendix).10 These barriers create a web of psychological considerations that

compound the ability and likelihood of staff members to report incidents.7 The

barriers result in a reporting deficit and an opaque culture that lacks meaningful

mechanisms with which to applaud “good catches” or learn from mistakes.11

Furthermore, evidence suggests that learning is also restricted at national levels. For

instance, the UK’s repository of all voluntary incident reports captures “a large

volume of high frequency, low intensity incidents” but provides a limited degree of

insight about the root causes of harm.12 This problem has been shown to inhibit

learning from incidents at local, national, and international levels.13,14

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3

Imperial College Healthcare National Health Service (NHS) Trust, the

organization referred to throughout this study, in collaboration with the National

Institute for Health Research’s Imperial Patient Safety Translational Research

Centre, initiated the intervention described here to shape its organizational safety

culture. The Trust is an NHS acute teaching hospital organization and major trauma

center in Northwest London with over 11,000 staff members across five hospital

sites. In comparison to the other thirty acute teaching hospitals in the English NHS,

the Trust is much larger: The median number of sites for similar organizations is four,

and the average total staff count is just 4,953.15 The organization serves a diverse

patient population, with approximately 125 million patient contacts per year—

including nearly 300,000 emergencies.

While revising local incident reporting policy appears to be a straightforward

organizational decision, evidence suggests that operationalizing cultural change is

not.16 Hence, this intervention employed evidence-based rigor to guide interventions,

adapting them with local codesign. Seven of the teams within the organization, four

of which include lay representation, explored incident reporting and learning as an

enabler of improving safety culture (exhibit 1).

Case-Study Context

At the outset of the intervention, a series of indicators across the organization

revealed a problem with safety culture. In 2016 the organization was rated 163 out of

203 in a UK-wide Learning from Mistakes League Table and classified as having

"significant concerns.”17 The league table was a simple ranking of all acute

organizations in the NHS and was developed based on key questions from the

National NHS Staff Survey relating to how staff perceived the fairness and

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effectiveness of incident reporting, their confidence in the reporting systems, and the

proportion of staff reporting that they had been bullied at work.17 This ranking was

used to suggest to organizations’ leadership whether they needed to improve their

ability to learn from mistakes. In addition to this ranking, the organization also

demonstrated poor patient safety culture metrics on the 2016 organizationwide Local

Staff Engagement Survey (exhibit 2).

In both 2016 and 2017 the organization also reported four never events,

defined as incidents that should never occur in medical practice—for example,

operating on the wrong body part or leaving surgical instruments inside a patient

after an operation. The list of never events is not fixed but is responsive to what are

deemed to be the most dangerous eventualities in health care, which can change

over time.18 While never events cannot be compared across organizations without

full context, only eighteen other organizations reported a figure as high or higher

during the same period.18

The combination of these indicators provoked action from the organization’s

executive board and underpinned a suite of interventions to improve safety culture.

The planning for this work took place in mid-2016, and the work itself began with

feedback gathering in October 2016. Interventions were launched in June 2017 and

evaluated iteratively over the course of the intervention cycle, ending in August 2018.

The aim of this work was to improve the incident reporting process at Imperial

College Healthcare NHS Trust and develop the foundations for a more just safety

culture. The intention was to use a translational, learning health system approach to

improving incident reporting and, over time, yield improved culture.

Study Data And Methods

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Translational Approach

The intervention used a translational approach. Translational refers to the

process of adapting evidence-based interventions to the practical needs of a health

care provider environment, with the support of embedded research expertise.

The technique has its root in a theory known as engaged scholarship, which

asserts the role of academic research principles in the practical context of

organizational social research and discourages the often removed position that

academics hold in solving practical problems.19,20

Interventions were introduced in an iterative way, meaning that feedback from

each helped inform subsequent interventions.21 They included codesign with a

seventy-person multidisciplinary group of patients, staff members, researchers, and

senior managers to solicit their feedback.3,22,23 The iterative nature of these

interventions reflects the improvement cycle model put forward in literature about

learning health systems that places a problem—in this case, how to foster a safety

culture—at the center and addresses it by collecting data, continuously analyzing

them, and making relevant changes.24,25 After initial feedback gathering and the

construction of a research aim, a cycle of evidence-based interventions was

implemented in a way that met the provider’s needs and retained the ability to apply

robust academic evaluation.

Measurement And Evaluation

Five indicators were continuously monitored throughout the duration of the

intervention cycle, from October 2016 to August 2018, including National NHS Staff

Survey results, Local Staff Engagement Survey results, incident reporting rates

measured against the organization’s patient activity data (i.e. how many patients are

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seen by the organization each month), reported levels of incident harm, and rates of

never events. Anecdotal feedback regarding staff perspectives on changes to

incident reporting and management was also collected.18

Analysis

This intervention included the continual collection and analysis of relevant

safety culture data, the results of which are reported below. The main findings relate

to improved staff engagement, increased incident reporting rates, and reduced rates

of never events. The results presented below, some of which have been published

previously,25 are based on survey data and data collected on various types of

events. We report results of tests of significance that compared pre-intervention and

post-intervention measurements, with additional details provided below.

Codesigned Interventions

Initial feedback gathering was conducted via Listening Events. These were

forums where front-line and managerial staff could articulate their ideas for improving

safety culture, facilitated by a trained researcher or member of the safety culture

team (details are available in the appendix).10 Seven evidence-based codesigned

interventions were then implemented (exhibit 3), followed by the assembly and

analysis of relevant data.25

The seven interventions were the introduction of the Incident Reporting

Reference Group; new reporting forms; local trigger lists for commonly occurring

incidents; new incident management processes; simpler approaches to incident

quality checking; anonymous reporting options; and the Learning from Excellence

program. The interventions were rolled out from October 2016 to August 2018. Their

specifications and the evidence supporting them are in the appendix.10

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Limitations

The main limitation of this work related to its translational approach, which

meant that elements of more robust research methods, such as randomizing and

blinding, could not be applied, given the constraints of working within a real health

care environment. Future work to simulate these interventions in randomized

controlled trials would bolster the academic evaluation. Alternatively, quasi-

experimental designs, such as nonequivalent groups and pre-post test designs,

would also provide a useful method with which to evaluate the interventions’ impact.

Study Results

Continuous Measurement

National NHS Staff Survey:

There were nonsignificant reductions (data not shown) in the number of staff

members who reported being bullied by other staff members and a significant (p <

0.05) increase in the percentage of staff members who witnessed potentially harmful

errors, near misses, or incidents in the past month (the increase in witnessing errors

is published as a problematic outcome; however, the increase could indicate a

positive shift toward increased reporting and openness about error).26

Local Staff Engagement Survey:

Local survey results demonstrated improvements on patient safety culture

metrics. From 2016 to 2017 and from 2017 to 2018, there were significant increases

in the percentage of staff members who reported that they felt safe and comfortable

about speaking up (exhibit 2). There were also significant increases from 2016 to

2017 in the percentages who believed that the organization encourages speaking up

and thought that care of patients was the organization’s top priority (exhibit 2). A new

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survey question was added in 2018 about whether staff members understood

incident reporting policies. Ninety-two percent of the staff reported that they did;

however, there were no points of comparison to other years to interpret the

significance of this finding.

Rates Of Incident Reporting, Harm, And Never Events:

There was also a significant increase in incident reporting rates over the

duration of the intervention cycle. An independent samples t-test that compared the

mean value for monthly incident reporting rates in 2016 (mean: 44.38; standard

deviation: 3.21) and 2017 (mean: 49.52; SD: 2.96) demonstrated a significant

increase in incident reporting rates (t = 4.40, d.f. = 22, p < 0.01) (exhibit 4).

Between 2016 and 2018 there were no significant differences in levels of

reported harm (see the appendix).10

Finally, the rate of reported never events fell from four per year in 2015 and

2016 to one in 2018 (data not shown), placing the organization in the normal range

for this rate for similarly sized organizations.

Intervention-Specific Findings

The measurements above were used to evaluate the suite of interventions

and feed into a cycle of continuous improvement. In addition, specific findings were

recorded about how staff members perceived the acceptability of each intervention

(see the appendix).10

The Listening Event feedback sessions involved 250 staff members who

discussed eight events and derived specific improvements necessary to enhance

incident reporting, which helped formulate the subsequent interventions.

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Of the seven interventions, six received positive feedback. The only

intervention not to be viewed positively was the new incident reporting management

process, as staff members did not find the new centralized process for signing off on

incidents useful to their services’ learning and development.

Furthermore, the Incident Reporting Reference Group met twelve times from

October 2016 to August 2018 to develop new incident reporting forms and oversee

the cycle of interventions. The group surveyed the staff about the new, streamlined

incident reporting forms. Seventy-six percent of respondents were satisfied with the

new forms. The process of developing the forms engaged staff and highlighted areas

where the forms did not reflect clinically relevant information or asked for

unnecessary information. In terms of the trigger list intervention, staff members felt

that such lists were helpful in engaging staff and raising awareness about common

incidents.

Despite some resistance to change before the interventions, both anonymous

reporting and the Learning from Excellence program were well received by the staff.

Eighty-two anonymous reports were made since the option was introduced in March

2018 to July 2018, which corresponds to 0.82 percent of all reports made across the

organization in that period. From April to August 2018, 126 positive reports were

made across the clinical areas that tested the Learning from Excellence program. In

the same clinical areas over the same time period, 163 negative incident reports

were submitted, which means that the positive reporting rate was 77 percent that of

the negative reporting rate.

Discussion

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Evidence about incident reporting suggests that while reporting systems are

plentiful and often rich in data, they are not always equipped to support learning and

can contribute to a blame culture.13,27,28 However, when implemented appropriately,

they can be a key feature of a learning health system.13,22

This case study explored a holistic approach to implementation, addressing a

range of concerns that restrict the ability of incident reporting to fuel a learning

culture.29 The experience of conducting the feedback gathering stage and keeping it

open to all staff resonated with theories of appreciative enquiry: that respecting staff

authority as commensurate to that of other stakeholders can solicit honest and

helpful views.30,31

Furthermore, results from the interventions demonstrated a general

enthusiasm, indicative of a cultural readiness for learning and improvement.32 This

was reflected in specific metrics about staff culture in the Local Staff Engagement

Survey results (exhibit 2) and in qualitative accounts from staff members, a key

source of information from which to advance the cyclical trajectory of improvement.24

Not all interventions were successful. Following the introduction of a new

incident management process, staff members articulated that they required more

details about events to generate learning. As evidenced extensively in the

organizational change literature, the psychological barriers to change in practice also

inhibited the effectiveness, rate, or both of the uptake of this intervention.33

In terms of the anonymous reporting intervention, evidence from other

organizations suggests that this intervention provides an option that helps staff

members feel safe to report, a feeling that is accepted to be a first step toward a just

culture.34 Results from this case study demonstrate that the intervention was

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welcomed by staff but not used often, which suggests that in the majority of cases,

the intervention did not obstruct root cause analysis.

This case study supports existing findings that academic research principles

can be adapted to support real-life hospital improvement cycles.12 While this work

benefited from organizational readiness, staff willingness, and executive

championship, the role of national policies was apparent in the sense that the

redesign of incident reporting forms was underpinned by the needs of mandatory

reporting to the national system.12,35

Impact On Policy

Impact on lpolicy at the local provider level has already been seen.

Incremental changes throughout the cycle of improvement included the

establishment of new policies that were successful at the pilot stage, such as the

new incident reporting forms, the removal of the senior manager quality checking

step in incident reviews, and the expanded rollout of the Learning from Excellence

program (see the appendix).10 Furthermore, a “no brief, no start” policy, which

ensures that surgical teams do not start work without a briefing about the operation,

was introduced based on feedback from the Listening Events. Finally, the

importance of having a positive staff culture is now articulated within the training

curriculum for staff preparing for their first management role. More specifically,

changes from the Listening Events were also integrated, so that there is now an

improved intranet and an organizationwide strategy for safety communications,

which includes how the CEO communicates safety-related information.

The role of local provider–level policies and practice should not be

overlooked. This work provides a precedent for using a cycle of staff- and patient-

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driven interventions to improve incident reporting and bolster reporting rates and

feelings of having a safer culture. The rigorous documentation associated with this

case study and considerable flexibility for local rather than academic ownership yield

substantial potential for knowledge transfer. While it is impossible to rerun full

intervention cycles in new settings, given the variation in teams, resources, and

operational structures, the method and results of this study provide the opportunity to

reflect on one learning health system’s cycle of improvements and derive a model for

implementation elsewhere. Vehicles such as the Academic Health Science Centres

in the UK and other academic, health care, and government partnerships across

systems internationally can support the diffusion of this work and its dissemination to

other organizations and policy makers.

The organization in this case study has identified emerging priorities related to

how to better learn from mistakes, and this work has already attracted interest

regionally in scaling up across other organizations in Northwest London. Work is

under way to take a safety culture baseline across three more organizations. The

next step is not only to continuously monitor, evaluate, and disseminate information

but also to invite critical inquiry from other interested organizations at the local or

national level to assess its value across geographies.

Conclusion

Improving safety culture in health care is a long-term process that demands

conviction for improvement and timely interventions that are aligned with the needs

of staff members and the preferences of patients. The continuous measurement

principles of learning health systems are congruent with the needs of practical

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improvement: Academic approaches have an important role to play in designing and

evaluating initiatives, although such approaches require flexibility and adaptation.

The results of the interventions from this case study are encouraging and

worthy of follow-up. The most impressive result, however, is that diverse teams and

hundreds of staff members have been engaged in the transformation process. This

input should be harnessed to support evaluation at this organization and reflected

upon to provide a blueprint for future cultural improvement cycles elsewhere.

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Notes

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content/uploads/2015/04/serious-incidnt-framwrk-upd.pdf</eref>

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[Internet]. London: NIHR Imperial Patient Safety Translational Research Centre;

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<jrn>13. Braithwaite J, Westbrook MT, Travaglia JF, Hughes C. Cultural and

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<jrn>19. Marshall M, Pagel C, French C, Utley M, Allwood D, Fulop N, et al. Moving

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EXHIBIT LIST

Exhibit 1: (Table) Exhibit 2: (Figure) Caption: Percentages of staff members at the Imperial College Healthcare National Health Service (NHS) Trust who agreed to the statements about safety culture shown from the Local Staff Engagement Survey in 2016–18 Source/Notes: SOURCE Authors’ analysis of responses to the Imperial College Healthcare NHS Trust’s Local Staff Engagement Survey. NOTES Significance refers to the difference from the previous year. The numbers of respondents to each question for 2016, 2017, and 2018 are shown below. a3,216, 2,766, and 3,131. b3,115. The item was introduced in 2018; see the text for more details. c3,201, 2,765, and 3116. d3,019, 2,568, and 2,950. e3,214, 2,755, and 3,133. **p < 0.05 Exhibit 3: (Table) Exhibit 4: (Figure) Caption: Patient safety incident reporting rates at the Imperial College Healthcare National Health Service Trust, 2016–18 Source/Notes: SOURCE Authors’ analysis of a statistical process control chart of organizational incident reporting rates. NOTES The upper and lower control limits are comparable to the standard deviation around the mean and can be interpreted in a similar way. The baseline mean in 2016 is 44.38, the calculated mean for 2017 was 49.52, and the difference is significant (α = 0.01).

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EXHIBITS

Exhibit 1: Teams involved in the Imperial College Healthcare National Health Service Trust (ICHNT) case study Teams   Responsibility   Number  of  people  on  

the  team  who  supported  this  work  

ICHNT  Safety  and  Effectiveness  Team  

Assurance  of  and  compliance  with  national  standards  and  external  reporting  requirements;  includes  lay  representation  

6  

ICHNT  Safety  and  Quality  Subgroup  

Subgroup  of  Executive  Quality  Committee  (chaired  by  the  medical  director);  reviews  risk  and  receives  assurance  from  divisions  and  corporate  directorates  on  matters  relating  to  quality  and  safety  in  the  Trust;  includes  lay  representation  

25  (committee)  

ICHNT  Safety  Culture  Steering  Group  

Steering  group  for  the  Trust  safety  culture  program  (chaired  by  the  medical  director),  which  aims  to  continuously  improve  the  safety  culture  in  the  Trust;  Includes  lay  representation  

20  (committee)  

ICHNT  Quality  Improvement  Team   Corporate  team  sitting  in  the  Medical  Director’s  Office  with  the  aim  of  creating  a  culture  of  continuous  improvement  in  the  Trust  through  the  use  of  quality  improvement  methodology,  supporting  core  program  aims,  and  service-­‐led  and  strategic  projects  

6  

ICHNT  Datix  Team   Part  of  the  Safety  and  Effectiveness  Team  with  responsibility  for  management  of  the  electronic  incident  reporting  management  system  

2  

Medical  Director's  Office   Corporate  executive  directorate  with  responsibility  that  includes  quality,  medical  education,  and  research  

6  

Patient  Safety  Translational  Research  Centre  

Generate  scientific  evidence  base  for  safety  and  support  implementation  of  evidence-­‐based  interventions  for  safety;  includes  lay  representation  

5  

SOURCE Institutional organization charts.

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Exhibit 3: Summary of interventions to improve incident reporting in the Imperial College Healthcare National Health Service Trust Intervention   Summary  

Feedback  gathering:  Listening  Events  

An  opportunity  for  front-­‐line  and  managerial  staff  to  express  their  priorities  for  cultural  improvement  across  the  organization  

Incident  Reporting  Reference  Group  and  Feedback  Survey  

A  multidisciplinary  group  set  up  to  make  incident  reporting  forms  more  user-­‐friendly  and  strengthen  staff  investment  in  learning  from  incidents  

Revised  incident  reporting  forms   Shortened  incident  reporting  forms  designed  to  increase  incident  reporting  rates  and  align  reporting  to  the  needs  of  subsequent  investigations  

Local  trigger  lists  for  incidents   A  list  of  common  incidents  produced  by  clinical  teams  to  increase  reporting  consistency  and  provoke  a  conversation  about  the  frequency  of  such  incidents  

New  incident  management  process  

A  policy  that  centralizes  the  incident  review  process,  enables  reporters  to  receive  timely  feedback,  and  reduces  the  burden  on  clinical  staff  to  review  incidents  

New  incident  validation  and  quality  checking  

A  process  designed  to  reduce  the  number  of  incident  investigations  awaiting  senior  manager  sign-­‐off  and  to  redirect  resources  from  administration  to  learning  

Anonymous  reporting  options   An  option  for  staff  to  report  anonymously  to  remove  the  possibility  for  blame  after  reporting  

Learning  from  Excellence  program  

A  mechanism  for  reporting  positive  occurrences  and  learning  from  best  practices  

SOURCE Authors’ summary of interventions.

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Acknowledgment

The research was supported by the Imperial Patient Safety Translational Research

Centre of the UK National Institute for Health Research (NIHR) and the NIHR

Biomedical Research Centre. The views expressed are those of the authors and not

necessarily those of the National Health Service, the NIHR, or the Department of

Health. An earlier version of the manuscript was presented at a working paper

review session in Washington, D.C., April 10, 2018, organized by Health Affairs and

supported by the Gordon and Betty Moore Foundation.

Bios for 2018-0706_Flott

Bio 1: Kelsey Flott ([email protected]) is a manager of the Patient Safety Translational Research Centre, Department of Surgery and Cancer, Imperial College London and St. Mary’s Hospital, in London, United Kingdom. Bio 2: Darren Nelson is head of quality compliance and assurance, Imperial College Healthcare National Health Service (NHS) Trust and St. Mary’s Hospital. Bio 3: Tammy Moorcroft is a program manager in the Safety and Effectiveness [please provide], Imperial College Healthcare NHS Trust and St. Mary’s Hospital. Bio 4: Erik K. Mayer is a [please provide], Surgery and Cancer, Imperial College London and St. Mary’s Hospital. Bio 5: William Gage is manager of the Safety Improvement Program, Imperial College Healthcare NHS Trust and St. Mary’s Hospital. Bio 6: Julian Redhead is CEO of the Imperial College Healthcare NHS Trust and St. Mary’s Hospital. Bio 7: Ara W. Darzi is executive chair of the World Innovation Summit for Health, Qatar Foundation, and director of the Institute of Global Health Innovation, Imperial College London.