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University of Calgary PRISM: University of Calgary's Digital Repository Graduate Studies Master of Public Policy Capstone Projects 2018-08-01 Funding Leads to Better Health Outcomes – Case study of Alberta Sepsis Network demonstrates how research initiative reduced mortality Haq, Anwar Haq, A. (2018). Funding Leads to Better Health Outcomes – Case study of Alberta Sepsis Network demonstrates how research initiative reduced mortality (Unpublished master's project). University of Calgary, Calgary, AB. http://hdl.handle.net/1880/109331 master thesis Downloaded from PRISM: https://prism.ucalgary.ca
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Page 1: Funding Leads to Better Health Outcomes Case study of ...

University of Calgary

PRISM: University of Calgary's Digital Repository

Graduate Studies Master of Public Policy Capstone Projects

2018-08-01

Funding Leads to Better Health Outcomes – Case

study of Alberta Sepsis Network demonstrates how

research initiative reduced mortality

Haq, Anwar

Haq, A. (2018). Funding Leads to Better Health Outcomes – Case study of Alberta Sepsis Network

demonstrates how research initiative reduced mortality (Unpublished master's project).

University of Calgary, Calgary, AB.

http://hdl.handle.net/1880/109331

master thesis

Downloaded from PRISM: https://prism.ucalgary.ca

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MASTER OF PUBLIC POLICY CAPSTONE PROJECT

Funding Leads to Better Health Outcomes – Case study of

Alberta Sepsis Network demonstrates how research initiative

reduced mortality

Submitted by

Anwar HAQ

Approved by Supervisor (Professor Herb Emery)

August 01, 2018

Submitted in fulfillment of the requirements of PPOL 623 and completion of the requirements for the Master of

Public Policy degree

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Acknowledgment

The author particularly acknowledges the advisor of this study,

Professor Herb Emery for his contributions to the knowledge, oversight

and excellent mentorship. Additionally, the author acknowledges

Snyder Institute for Chronic Diseases, University of Calgary for tuition

assistance, ASN Manager Ms. Knight for sharing ASN related

information, AHS DIMR office for the data, Ms. Farahnaz Bandali for her

support and encouragements over the years, and Julie-Anne Babiuk for

reviewing the document.

Last but not least, the support from my family that kept me intact

during some of the toughest moments in our life.

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TABLE OF CONTENTS

EXECUTIVE SUMMARY ............................................................................................. VII

INTRODUCTION .......................................................................................................... 1

HISTORY OF RESEARCH FUNDING IN ALBERTA......................................................................................................... 3

INTERDISCIPLINARY TEAM GRANTS (ITGS) ............................................................................................................ 4

WHAT IS SEPSIS ............................................................................................................................................... 6

WHY ALBERTA SEPSIS NETWORK (ASN) .............................................................................................................. 7

STUDY POPULATION ......................................................................................................................................... 8

DATA SOURCES ................................................................................................................................................ 9

RESULTS ................................................................................................................... 10

SEPSIS CASES ACROSS ALBERTA ......................................................................................................................... 10

CONFIRMED DIAGNOSIS SEPSIS CASES AT IN-PATIENT AND EMERGENCY DEPARTMENTS IN ALBERTA ................................ 11

Non-ASN IP and ED Sites - combined ................................................................................................... 11

ASN IP and ED Sites - combined ........................................................................................................... 12

Non-ASN and ASN IP Sites .................................................................................................................... 13

Non-ASN and ASN ED Sites ................................................................................................................... 13

QUERY DIAGNOSIS SEPSIS CASES AT IN-PATIENT AND EMERGENCY DEPARTMENTS IN ALBERTA ....................................... 14

Non-ASN IP and ED Sites - combined ................................................................................................... 15

ASN IP and ED Sites - combined ........................................................................................................... 15

Non-ASN and ASN ED Sites ................................................................................................................... 15

SEPSIS MORTALITY RATE FOR NON-ASN AND ASN SITES ACROSS ALBERTA ................................................................ 17

Non-ASN IP and ED Sites - combined ................................................................................................... 17

ASN IP and ED Sites - combined ........................................................................................................... 18

MORTALITY RATE AMONG CONFIRMED SEPSIS CASES FOR NON-ASN AND ASN SITES ACROSS ALBERTA .......................... 19

Non-ASN IP and ED Sites - combined ................................................................................................... 20

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ASN IP and ED Sites – combined........................................................................................................... 20

Non-ASN and ASN IP Sites .................................................................................................................... 22

Non-ASN and ASN ED Sites ................................................................................................................... 24

MORTALITY RATE AMONG QUERY SEPSIS CASES FOR NON-ASN AND ASN SITES ......................................................... 24

SUMMARY OF RESULTS ............................................................................................ 26

DISCUSSION ............................................................................................................. 28

WHY GOVERNMENT FUNDING IS IMPORTANT ...................................................................................................... 30

CONCLUSION AND RECOMMENDATIONS .................................................................. 33

APPENDIX I ............................................................................................................... 37

KEY OBJECTIVES OF ALBERTA SEPSIS NETWORK ................................................................................................... 37

APPENDIX II .............................................................................................................. 38

PARAMETERS AND LIMITATIONS FOR DIAGNOSTIC DATA........................................................................................ 38

APPENDIX III ............................................................................................................. 39

PARAMETERS AND LIMITATIONS FOR MORTALITY DATA ........................................................................................ 39

REFERENCES ............................................................................................................. 40

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LIST OF FIGURES

FIGURE 1: SEPSIS CASES QUERIED AND CONFIRMED DIAGNOSED AT ASN IP AND ED SITE. 11

FIGURE 2: SEPSIS CASES QUERIED AND CONFIRMED ACROSS ALBERTA EXCLUDING ASN SITES. 11

FIGURE 3: SEPSIS CASES CONFIRMED DIAGNOSED FOR NON-ASN AND ASN SITES FOR ALL FACILITIES TYPE ACROSS

ALBERTA. 12

FIGURE 4: SEPSIS CASES CONFIRMED DIAGNOSED AT NON-ASN AND ASN IP SITES ACROSS ALBERTA. 13

FIGURE 5: SEPSIS CASES CONFIRMED DIAGNOSED AT NON-ASN AND ASN ED SITES ACROSS ALBERTA. 14

FIGURE 6: SEPSIS CASES QUERY DIAGNOSED AT NON ASN IP AND ED SITES ACROSS ALBERTA. 15

FIGURE 7: SEPSIS CASES QUERY DIAGNOSED AT ASN IP AND ED SITES ACROSS ALBERTA. 16

FIGURE 8: SEPSIS CASES QUERY DIAGNOSED AT NON ASN AND ASN ED SITES ACROSS ALBERTA. 16

FIGURE 9: SEPSIS RELATED MORTALITY RATES AMONG NON-ASN SITES ACROSS ALBERTA. 17

FIGURE 10: SEPSIS RELATED MORTALITY RATES ACROSS ASN SITES. 18

FIGURE 11: SEPSIS RELATED MORTALITY RATES FOR CONFIRMED SEPSIS CASES ACROSS NON-ASN IP AND ED SITES.

20

FIGURE 12: SEPSIS RELATED MORTALITY RATES FOR CONFIRMED SEPSIS CASES ACROSS ASN IP AND ED SITES. 21

FIGURE 13: SEPSIS RELATED MORTALITY RATE FOR CONFIRMED SEPSIS CASES ACROSS NON-ASN IP SITES IN

ALBERTA. 22

FIGURE 14: SEPSIS RELATED MORTALITY RATE FOR CONFIRMED SEPSIS CASES ACROSS NON-ASN IP SITES IN

ALBERTA. 23

FIGURE 15: SEPSIS RELATED MORTALITY RATES FOR CONFIRMED SEPSIS CASES ASN ED SITES. 25

LIST OF TABLES

TABLE 1: SEPSIS RELATED MORTALITIES ACROSS ASN SITES. 19

TABLE 2: SEPSIS RELATED MORTALITIES ACROSS NON-ASN SITES. 19

TABLE 3: SEPSIS RELATED MORTALITIES FOR CONFIRMED SEPSIS CASES ACROSS NON-ASN SITES. 21

TABLE 4: SEPSIS RELATED MORTALITIES FOR CONFIRMED SEPSIS CASES ACROSS ASN SITES. 21

TABLE 5: SEPSIS RELATED MORTALITIES FOR CONFIRMED SEPSIS CASES ACROSS NON-ASN SITES. 23

TABLE 6: SEPSIS RELATED MORTALITIES FOR CONFIRMED SEPSIS IP CASES ACROSS ASN SITES. 24

TABLE 7: MORTALITY RATES AMONG CONFIRMED SEPSIS CASES AT ED SITES WITHIN ASN SITES. 25

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LIST OF ABBREVIATIONS

AHS: Alberta Health Services

ASN: Alberta Sepsis Network

DIMR: Data Integration Measurement and Reporting

ED: Emergency Department

IP: In-patient

UCC: Urgent Care Center

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EXECUTIVE SUMMARY

Alberta’s spending on healthcare has outpaced both economic growth and growth in

government revenue, and its access to services and health outcomes are only comparable to

provinces and countries that spend much less. Plenty of literature exists in favour of

investments in biomedical research benefiting patients and society. While many of these

studies looked at the impact of research funding at program level, this paper reviewed one of

the five Interdisciplinary Team Grants (ITGs) – the Alberta Sepsis Network (ASN). The project

was funded by the Alberta Innovates. Using the ASN as a case study, we aimed to find evidence

if investment in sepsis research contributed toward better health outcomes such as reduced

mortality for individuals with sepsis across in-patients (IPs) and Emergency Departments (EDs)

in Alberta.

The raw sepsis data was requested from Alberta Health Services’ (AHS) administrative

data system called DIMR (Data Integration Measurement and Reporting). The sepsis data for

this study was complex and presented as confirmed sepsis diagnosis and query sepsis diagnosis

for IPs and EDs across Alberta. Since the ASN team had specific focus on certain sites in Calgary

and Edmonton, each data group was categorized as either non-ASN site data or ASN site data

and compared as evidence of impact.

For overall sepsis cases confirmed as well as queried across IP and ED, the number of

sepsis cases increased over the study period (2003 to 2016) both for non-ASN and ASN sites.

However, increases in sepsis cases for ASN sites was higher compared to non-ASN particularly

during the ASN project period of 2010 to 2016. Furthermore, a similar pattern was also

recorded when the data was further separated as confirmed sepsis cases or query sepsis cases

within IP or ED. The increased number of confirmed sepsis cases was, in particular, higher for

ASN facilities during the ASN project period of 2010 to 2016. In addition, data also revealed that

IP departments showed a larger increase in sepsis cases compared to ED. The only exception to

this was query diagnosed sepsis cases both for non-ASN as well as ASN sites.

Considering ASN focused sites, sepsis mortality trends were similar to that of sepsis

diagnosis data trends for ASN facilities. A higher reduction in mortality rates was observed

during the ASN period of 2010 to 2016 for ASN sites when compared to non-ASN sites. This can

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be attributed to additional staff dedicated to ED departments within ASN sites. The reduction in

mortality rates were only observed for ASN IP sites for confirmed sepsis diagnosed cases;

mortality data from query sepsis cases and from ED sites both for non-ASN and ASN sites

remained non-conclusive.

Research in general is an expensive undertaking with delayed or difficult to capture

benefits. Despite the complexity around sepsis data, this case study was able to demonstrate

that the investment in ASN research had concrete impacts on patients’ lives that made it

worthwhile. While it is difficult to put a direct value for money for this publicly funded research,

the sepsis data has suggested that the ASN might have saved lives particularly within ASN

focused sites. Additionally, the investment in ASN offered a wide range of benefits that

ultimately improved innovation and continue to save lives in other areas that have not been

captured under this case study. Since government has capacity to trigger innovation and take

larger risks, it should not hesitate to invest in research. Researchers and policy makers must

work jointly to familiarize themselves with the research value chain and influence decision

makers to not shy away from investing in research programs such as ASN.

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INTRODUCTION

In order to develop new knowledge that will impact the health of Albertans and improve

the healthcare system through translation of research, Alberta Heritage Fund for Medical

Research (AHFMR) funded ten Interdisciplinary Team Grants (ITGs). This paper will review one

of the five successful programs in the second cohort, the Alberta Sepsis Network (ASN), as a

case study for its impact on the health of Albertans and provincial healthcare system. Using the

ASN as a case study will help accept or reject the hypothesis that research funding contributed

toward better health outcomes for individuals with possible symptoms of sepsis or septic shock

admitted to the various facilities in particularly within ASN focused sites. This paper will also

examine the indirect impact of the knowledge generated through this program on Albertans’

health and policy shifts in any form.

Alberta has high and growing health expenditures; there are issues with system access

and the health outcomes are comparable to those observed in provinces and countries that

spend much less on their health systems. In Alberta, spending on healthcare has outpaced both

economic growth and growth in government revenue. The result is an increasing share of

government spending going towards healthcare. With an annual per capita expenditure of

$7329, Alberta spends over 41% of its budget on healthcare and ranks as the second highest

provincial per capita spender after Newfoundland and Labrador.1 Accounting for age and

gender, Alberta spends the most per capita in Canada. Even with higher spending, Alberta’s

health system is not one of the best among the provinces and faces several long-term and

short-term challenges. Generally, it is an average performer with respect to population health,

ranking in the middle on life expectancy and an increasing number of services are going from

publicly to privately funded.

This situation begs the question of how we can reduce healthcare costs and increase

value by improving patients’ experience and health outcomes. The solution is not to inject huge

amounts of cash, merely making hospitals cheaper or to ration services, but to improve the

existing system through innovation. The system requires technological, procedural and

1 Canadian Institute for Health Information. National Health Expenditure Trends, 1975 to 2017. Ottawa, ON: CIHI;

2017.

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organizational innovation, both in inputs and how services are delivered, so that the

government can derive greater value for the money it is investing.

With over $13 billion worth of research activities currently ongoing,2 Canadian

universities remain the second largest performer of research in Canada after industry. Its

importance cannot be underestimated as federal and provincial governments jointly remain the

largest funder of the university research. Federal and provincial governments, industry, public,

and non-profit organizations are the main funders of research in Canadian universities.

According to the Association of Universities and Colleges of Canada (AUCC), Canadian

universities perform over $12 billion worth of research activities. Compared to other OECD

countries, Canada spends a higher share of its GDP on postsecondary education and research.

Even with this distinction, researchers are often concerned that the current funding structure

and trends in the amount of dollars available for the research are major roadblock for their

career to take-off and ideas to materialize.

One of the stumbling blocks for research organizations, such as hospitals, and research-

intensive universities, is their access to the research funding and unpredictability of the funding

cycle. This undermines their ability to expand research and innovate and results in researchers

across Canada facing fierce competition in securing funding. Since research plays an important

role in the wellbeing of the public, the wellbeing of the research enterprise becomes a serious

concern and a priority matter for policy practitioners as well as the public.

There is a general and widespread consensus that investment in biomedical research

brings benefit to patients and society (Krzyzanowska, Kaplan and Sullivan 2011, and Olson and

Merril 2011). On a provincial level, Zwicker and Emery (2015) have also correlated mortality

from potentially avoidable causes with research funding in Alberta. They concluded that

research funding enhances health research capacity that directly impacts health outcomes.

Despite these positive correlations, there are controversies around biomedical research

funding allocation methods among various diseases as the funding levels do not always match

2 Universities Canada. Universities Facts and stats, an overview [Source Statistics Canada, Gross Domestic

Expenditure on R&D in Canada, 2016]. https://www.univcan.ca/universities/facts-and-stats/

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with the range of disease burdens such as prevalence, incidence, mortality, and economic costs

(Vermus 1999, Gross, Anderson and Powe 1999).

Since Zwicker and Emery’s (2015) paper looked at the overall research funding on

health outcomes, the current study takes Zwicker and Emery’s premises a step further. This

paper will look at the impact of the research funding at a program level using an

Interdisciplinary Team Grant (ITG) program funded by the Alberta Innovates Health Solutions3

(formerly known as Alberta Heritage Fund for Medical Research – AHFMR). This study aims to

determine if total funding is contributing to better health outcomes, if this also happens at the

program level. The premise of this paper is that the impact of such research funding goes

beyond traditional peer review publications. As the knowledge generated through these

programs is used to improve patient care and the management of diseases, it results in better

outcomes. This study would further aim to establish a link between random policy shifts in

funding various programs and its unintended consequences of truncated innovation cycle

resulting in larger sunk-costs, poor cost recoveries and negative impact on patients’ outcomes

in the area.

History of research funding in Alberta

On a national level, the Canadian Institute for Health Research (CIHR) is the federal

agency responsible for funding medical research in Canada. Alongside CIHR, larger provinces

also have provincial funding agencies that either fund independent research programs or match

federal funding. In Alberta, this task is undertaken by the Alberta Innovates Health Solutions

(AIHS). AIHS was formerly known as the Alberta Heritage Foundation for Medical Research

(AHFMR).3

In 1980, in order to support biomedical and health research at Alberta universities and

other affiliated institutions, the Alberta government introduced the Alberta Heritage

Foundation Medical Research Act (Revised Statutes of Alberta, 2000).4 This act was the

3 While this report was being written, AIHS went through another transition where all four arms of Alberta

Innovates merged and is now Alberta Innovates (AI). This paper examines how AIHS funding for health research is contributing towards healthcare innovation, reducing suffering and improving the lives of Albertans.

4 Alberta Heritage Foundation for Medical Research Act, RSA 2000, c A-21, http://canlii.ca/t/knwx

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foundation for the establishment of the AHFMR. With the objective,5 “to support community of

researchers who generate knowledge, the application of which improves the quality of life of

Albertans and people throughout the world” an initial investment of $300 million was made.

The money came from the interest revenue from a government endowment.

During next 25 years the AHFMR provided an unprecedented recruitment opportunity

that brought the best and the brightest researchers and clinician scientists to Alberta, not just

from other parts of Canada, but from across the world. The result was amazing. This supported

over 8,500 positions where AHFMR provided extraordinary opportunities to further their

research career.

Another characteristic of AHFMR carried was its at-arms-length relationship to the

government. AHFMR was headed by a President who was CEO of the organization. The Board of

Trustees were advised by an independent international Scientific Advisory Council. AHFMR was

responsible to Albertans through the minister of Advance Education and Enterprise. Because of

this independent structure there was minimal or no interference from the government towards

how research funding was granted. The President and CEO of the organization was responsible

for all of these decisions.

Interdisciplinary Team Grants (ITGS)

For the most part, AHFMR invested in individual investigators. The strategic intention

was to support health research in Alberta. Most of the funding programs were developed to

offer broader but competitive opportunities to individual investigators and investigators-in-

training.

In 2007 AHFMR recognized that a tremendous research capacity had been built in

Alberta and that better coordination could harness this excellence and address important and

complex health challenges. This led to a strategic shift in the Board, organizational structure,

and vision during 2007. The Board advised AHFMR to utilize some of the new resources to

invest in collaborative and interdisciplinary research grants. This led to the Interdisciplinary

Team Grants (ITG) Program. The program aimed to provide opportunities for high-quality,

5 Objectives taken from, Alberta Heritage Foundation for Medical Research Act, RSA 2000, c A-21,

http://canlii.ca/t/knwx

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internationally recognized teams of investigators to complete research initiatives with defined

health outcomes.6 Up to $1M per year per team for up to five years was provided to support

collaborations on health problems or issues in the defined areas of research that aligned with

strategic research priorities of AIHS (AHFM at the time).

The specific objectives7 of the ITG program were to:

1. Support the production of high-quality research that addresses important and complex

health issues, and which requires a collaborative team approach;

2. Support interdisciplinary and multi-institutional teams of talented researchers;

3. Provide superior interdisciplinary research training and mentorship;

4. Engage end-users in the production and translation of research findings to improve the

health of Albertans or the health care system.

The abovementioned objectives of the ITG program clearly emphasised new knowledge

for impacting the health of Albertans and Alberta’s healthcare system through translation and

transfer of this new knowledge to the relevant end user.

These objectives led to the first cohort of Interdisciplinary Team Grants (ITG) Program

by AHFMR. A total of five teams were announced in 2007. Another cohort of an additional five

teams was announced in 2008. Although the guidelines indicated that the interdisciplinary

team could apply for renewal for another five-year term, none of the teams was renewed.

Alberta Sepsis Network

The Alberta Sepsis Network (ASN) was one of the ten ITGs that secured a total funding

of $5 million from the AIHS. The project started in April 2009 and ended March 2015. Although

the Network was led by the physician and researchers from the Cumming School of Medicine,8

it truly was a pan-province research program. Through collaboration the ASN was able to bring

together intensive care physicians, infectious diseases specialists, psychologists, and a wide

range of basic scientists from the University of Alberta, University of Calgary, University of

6 http://www.aihealthsolutions.ca/funding/health-research-funding/legacy-funding-

opportunities/interdisciplinary-team-grants-itgs/

7 http://www.aihealthsolutions.ca/media/ITG-Guidelines.pdf

8 Formerly known as the Faculty of Medicine.

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Lethbridge, Alberta Health Services, Primary Care Networks, and other groups. The clinicians

and the researchers spanned a wide range of disciplines.

Although the Network had multiple objectives and goals, two9 of the objectives stood

out in terms of health outcomes and their potential spill-over to the most important goal of the

Network, to revolutionize the diagnosis and treatment of septic patients. The ASN promised a

paradigm shift in the way research was conducted at the level of basic science and clinical

practice for sepsis. Over the next six years (after receiving a one-year extension) the Network

used a systematic and coordinated approach to learn how to treat different septic infections

effectively. Each septic patient that entered an Intensive Care Unit (ICU) or pediatric ICU in

Alberta was enrolled in the program and tested for biomarkers. The ASN’s multidisciplinary

program identified ways to treat different septic infections effectively, changing the treatment

plans and making targeted intervention a reality.

What is Sepsis

Sepsis10 and septic shock is a complex medical problem requiring multidisciplinary care

and is one of the top ten leading causes of death in Alberta. Commonly referred as a systemic

infection, sepsis is a generic term to describe a group of infectious diseases. Sepsis occurs when

an infection you already have, in your skin, lungs, urinary tract or somewhere else, worsens

until it involves the whole system of the body.11 In response to this systemic infection, the body

responds in extreme by shutting down various systems and resulting in organ failure. Sepsis

indiscriminately affects individuals of all ages, sexes and socio-economic status. Patients with

sepsis may become critically ill, resulting in single or multiple organ failure and possible

amputation or death. With a 30-50% mortality rate, sepsis occurs in over 18 million individuals

worldwide each year including 750,000 North Americans and 30,000 Canadians.12 In Canada,

9 Objectives - Development of new science and technology, which will serve as the basis for first and foremost

early sepsis detection leading to a complete paradigm shift in clinical trials design. Objective- An integrated clinical network of standardized care to provide optimal care of Albertans with sepsis

10 Adopted from Alberta Sepsis Network, Interdisciplinary Team Grant proposal.

11 Sepsis – Basic Information, Centers of Disease Control and Prevention. Last updated January 23, 2018. https://www.cdc.gov/sepsis/basic/index.html

12 Surviving Sepsis Campaign, Background, 2016. http://www.survivingsepsis.org/Background/Pages/default.aspx

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sepsis is responsible for an estimated 9,320 deaths every year, representing 10.9% of total

deaths occurring in hospitals.13 According to the Canadian Association for Critical Care Nurses

(CACCN), patients who suffered from sepsis during their hospitalization were 56% more likely to

die than those diagnosed on admission.14 The CACCN further elaborated that a typical episode

of sepsis increased hospital resource utilization and prolonged the average stay in intensive

care units by an additional nine days of median hospitalization. While early detection and

interventions with timely antibiotics is associated with enhanced outcomes,15 those who

survive suffer long-term health impairments. In addition, mortality rates are much higher in

rural areas. This is, in part, because early detection is difficult, and management of these

patients require specialized expertise, resources and facilities.

Caring for critically ill patients amounts to approximately 15-30% of all hospital costs.16

With over 65% of all patients with severe sepsis being admitted to ICU, these patients become a

major cost driver for the total ICU costs.17

Why Alberta Sepsis Network (ASN)

With an average cost of $37,000/patient, Alberta spends over $100,000,000 a year on

critical care.18 In terms of mortality, morbidity and cost burden, sepsis ranks closer to cancers,

cardiovascular diseases and other infectious diseases such as HIV-AIDS. However, sepsis has not

received the same level of attention translating into funding for sepsis research or

advancements in new therapies. As the advancements in the technology and treatments have

enhanced the prognosis for cancers and cardiovascular diseases, mortality due to sepsis has not

13 Canadian Institute for Health Information, In Focus: A National Look at Sepsis (Ottawa, Ont: CIHI 2009)

14 D. C. Angus et all., “Epidemiology of Severe Sepsis in United States: Analysis of Incidence, Outcome, and Associated Cost of Care, “Critical Care Medicine 10 (1992): pp. 81-88.

15 Huange, D.T., T.M. Osborn, T. M., Gunnerson, K. J., Gunn, S.R., Trzeciak, S., Kimball, E., Fink, M. P., Angus, D. C., Dellinger, R. P., and Rivers, E. P. (2005). Critical care medicine training and certification for emergency physicians. Crit Care Med., 33:2104 Ref ID:3667

16 Jacobs, P., and Noseworthy, T.W. (1990). National estimates of intensive care utilization and costs: Canada and the United States. Crit Care Med. 18: 1282.

17 Wang, H.E., Shapiro, N. I., Angus, D. C., and Yealy D. M. (2007). National estimates of sever sepsis in United States emergency department. Crit Care Med. 35: 1928. Ref ID:3696.

18 Lee, H., Doig, C. J., Ghai, W. A., Donaldson, C., Johnson, D., and Manns, B. (2004). Detailed cost analysis of care for survivor of sever sepsis. Crit Care Med. 32:981. Ref ID:3680.

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improved for a long time. Worst of all increases in antibiotic resistant in bacteria and

compromised immune systems because of other therapies contribute an increased incidence of

sepsis cases, especially in older patients. As our age demographics change and people are living

longer, we could see a lot more sepsis cases in the future. Programmes such as ASN can have

major impact on early detection and improved treatment of sepsis cases, decreasing the

burden placed on our health system.

Study Population

This study is based on a multi-site retrospective cohort data consisting of adult and

paediatric patients for both confirmed and query sepsis cases for all Alberta provincial sites that

report data to AHS. Data was stratified by fiscal year (April 1 to March 31), AHS zones, age

category (age at time of admission/visit), whether the case was confirmed or a query diagnosis,

and by type of department (acute care in-patient [IP], emergency department [ED], urgent care

centre [UCC], or continuing care [CC]). The volumes of cases reported here are from 2003 to the

most current data in 2016. The start date for reporting varied across facilities.

It is important to know that there was a substantial limitation to the data because the

volumes reported cannot be assumed to be mutually exclusive, or, alternatively, subsets, of

each other. For example, sepsis cases reported in CC facilities might also be the same case(s)

reported in the ED/UCC or IP setting if a resident or patient was transferred from one sector to

another. Since patient data was not collected, the database was unable to sort these

duplications. Therefore, the number of cases reported in IP and ED/UCC were treated

separately instead of adding them together. In addition, cases of a confirmed or query sepsis

diagnosis in ED/UCC cannot be assumed to be the same sepsis case in an IP setting; a sepsis

diagnosis in ED/UCC may be ruled out in an IP setting and thus not coded or captured on the IP

abstract. Alternatively, a patient admitted through ED may not have a sepsis diagnosis

identified until later in their IP visit. In this case, a sepsis diagnosis would not appear on the ED

abstract, but would be coded on the IP record. Sites with fewer than ten sepsis cases for the

fiscal year have been combined to comply with AHS privacy regulations.

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Data Sources

The study population was extracted from AHS’ administrative data system called DIMR

(Data Integration Measurement and Reporting). DIMR helps healthcare providers and clients

collect and report information about health within AHS including health status, health

determinants, and use of healthcare services. The database also consults on epidemiologic

methods.19 Because of the patients’ confidentiality, the DIMR data is not accessible publicly. In

order to request the required sepsis data, an Analysis Reporting form was submitted to the

DIMR intake coordinator in the Calgary region. Since only the volume of patients coded for

sepsis queries, sepsis diagnosis, or mortality numbers were required, without any patient

identifier (such as name or address), no additional ethics approval was required. The data was

received in Microsoft Excel format.

19 http://www.albertahealthservices.ca/info/service.aspx?id=1661

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RESULTS

Sepsis cases across Alberta

Sepsis case data was reported as confirmed and query diagnosis across In-Patient (IP)

Critical Care departments and Emergency Departments (ED). To determine if Alberta’s

investment in ASN impacted sepsis patients a complete set of data for confirmed and query

sepsis diagnosis for both department types was separated from ASN sites and plotted (Figure

1). As two of the ASN team leaders and co-leaders were based out of Calgary and Edmonton,

the ASN had easy access to the Foothills Hospital, Rocky View Hospital, Alberta Children’s

Hospital, Peter Lougheed Centre as well as Stollery Children Hospital. One of the focuses of this

study is to compare general sepsis data to that of the sites where ASN researchers had an

added focus. Therefore, sepsis data pertaining these sites was separated from the remaining

and plotted.

In general, the total number of sepsis cases showed an upward trend during the

reported period of 2003 to 2016 (Figure 1). However, the increase in the number of sepsis cases

was higher between 2010 and 2016. During first 8 years (before the ASN was in place), the

sepsis cases increased from 4873 in 2003 to 5628 in 2010, representing a 15 percent increase in

the number of cases from the base year 2003. Sepsis cases increased at a higher rate between

2011 to 2016; during this period number of cases increased from 5628 in 2010 to 8380 in 2016,

a 49 percent increase in sepsis cases from the base year 2010 when ASN was launched (flagged

as red boxed arrow on each figure).

Similar to the non-ASN sites as shown in (Figure 1), the ASN sites also showed an

increase in sepsis cases across the board (Figure 2). During the pre-ASN period of 2003 to 2010,

the sepsis cases increased from 1650 in 2003 to 2373 in 2010, an increase of over 43 percent in

sepsis cases during this period. However, the number of sepsis cases increased at a much

higher rate during the ASN period of 2010 to 2016. The number of cases increased from 2373 in

2010 to 5043 cases in 2016 representing a 112 percent increase from the base period of 2010.

Considering that the number of ASN sites was less than that of non-ASN sites, this increase in

sepsis cases represents a much higher number of cases for ASN sites.

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Confirmed diagnosis sepsis cases at in-patient and emergency departments in Alberta

In order to find the real source of the increases in sepsis cases, the data shown above in

Figure 1 and Figure 2 was further separated into two major groups: confirmed sepsis diagnosis

cases or query diagnosis sepsis cases and plotted together as Figure 3.

Non-ASN IP and ED Sites - combined Confirmed sepsis diagnosis data for patients who visited non-ASN in-patient (IP) and

Emergency Departments (ED) sites across Alberta showed a general increase in numbers of

sepsis cases throughout the reported period between 2003 to 2016 (Figure 3, green bars).

During 2003 to 2010 the sepsis cases in non-ASN sites increased from 3961 to 4702,

representing about 18.7 percent increase from the base year 2003. However, the number of

sepsis cases increased at a higher rate during ASN period (2010 to 2016). During this six-year

4873 5035 5259 50245444 5589

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Figure 2: Sepsis cases queried and confirmed across Alberta excluding ASN sites.

Figure 1: Sepsis cases queried and confirmed diagnosed at ASN IP and ED site.

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period, the number of confirmed sepsis cases increased from 4702 in 2010 to 6907 in 2016, a

47 percent increase from the base year of 2010 when ASN was launched.

ASN IP and ED Sites - combined A similar trend of an increase in the number of sepsis was also observed for confirmed

diagnosed cases for ASN sites (Figure 3, red patterned bar). During the pre-ASN period, the

number of confirmed sepsis cases for these facilities increased from 1243 in 2003 to 2017 in

2010. However, the rate of increase in confirmed sepsis cases for these sites was higher during

2010 to 2016, the duration of ASN project. For this period, ASN site cases increased from 2017

in 2010 to 4411 in 2016, a 118 percent increase in sepsis cases. In 2016 alone, there was an

increase of 1461 sepsis cases among ASN sites from the previous year. This was unusual,

however, review of the data showed a sharp increase in confirmed sepsis cases across all ASN IP

sites as well as ASN ED sites. The higher number of confirmed sepsis cases for these ASN sites

compared to non-ASN sites may be attributed to an increase of staff recruited by ASN at some

of the locations within Edmonton and Calgary, along with two of the main project leads being

located in Calgary. Although the number of cases as well as the trend of increase in the number

of cases look similar between the non-ASN facilities and ASN focused facilities, it is important to

note that the absolute number of sepsis cases will always remain higher for non-ASN sites

because of the number of non-ASN sites across Alberta was much higher than the ASN sites.

Figure 3: Sepsis cases confirmed diagnosed for non-ASN and ASN sites for all facilities type across Alberta.

39614163 4225 4040

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1867 1999 2064 20172255

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Non-ASN and ASN IP Sites To make further sense of the data in Figure 3 and find if the source of higher number of

sepsis cases is IP or ED, the data was further separated into department type (either IP or ED)

for both non-ASN as well ASN focused sites. When the data from non-ASN sites and ASN sites in

Figure 3 was separated according to the department types (IP and ED) and plotted, a 119

percent increase in the sepsis cases was observed for ASN sites over the project period when

base year 2010 was compared to 2016 (Figure 4 red bars with pattern). Over a similar period

the non-ASN facilities showed a much smaller increase of 47.9 percent (Figure 4, green bars). As

mentioned for Figure 3, the increase of 842 sepsis cases for ASN facilities during 2016 alone was

an unusual for one year alone (Figure 4 red patterned bars). This increase was traced to a sharp

increase in confirmed sepsis cases across ASN IP sites (both pediatric and adult cases). It is

difficult to say why this happened.

Non-ASN and ASN ED Sites

An exact trend of increasing confirmed sepsis cases was also observed across non-ASN

and ASN ED sites. However, during the ASN period non-ASN sites showed a 70 percent increase

in sepsis cases, whereas ASN sites increased by 119 percent (Figure 5). The sharp increase in

confirmed diagnosed ASN ED sites during 2016 was traced to an increased number of

confirmed sepsis case among adult patients (age related data not shown).

25602777 2716

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Figure 4: Sepsis cases confirmed diagnosed at non-ASN and ASN IP sites across Alberta.

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Query diagnosis sepsis cases at In-patient and emergency departments in Alberta

The total sepsis cases data shown in Figure 1 includes two major categories; confirmed

sepsis diagnosis and query sepsis diagnosis. Figure 3, Figure 4, and Figure 5 contained data for

confirmed sepsis diagnosed cases for non-ASN and ASN sites. The section below covers another

category of the sepsis cases: query diagnosis sepsis cases. A query diagnosis is one that is

suspected, but not confirmed at the conclusion of a patient visit or at the time of a patient’s

discharge. They may have been later confirmed, ruled out (not the diagnosis), or have no

further diagnosis information (data limitation). These are cases where a diagnosis/medical

condition are possible or likely but have not been confirmed. As mentioned before, due to the

lack of patient identifiers, it is impossible to tell which if these cases were later confirmed and

included in the confirmed data set discussed above.

Similar to confirmed sepsis cases, query sepsis cases data both from IP and ED was

analysed. In light of the ASN program, an increase in query diagnosis should be also be

expected during the ASN program period.20 When the query diagnosis cases from both IP and

ED were clustered and plotted, both non-ASN as well ASN sites showed an upward trend in

20 For example, if a patient came in with tachycardia, elevated BP, high WBCs and had suspected sepsis, this would

be coded as a query sepsis diagnosis. It’s possible that a) the sepsis was confirmed during a later healthcare encounter, b) sepsis was ruled out during a subsequent health encounter and another reason for the symptoms was diagnosed, or another query diagnosis established, or c) there were not any further healthcare encounters recorded and it is not known whether the patient was treated by their family doctor or other community health provider for sepsis (or for another condition), or not treated at all and the symptoms self-resolved (as per DIMR).

1401 13861509 1464

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2003 19322129

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521 517 549692

887 967 992 948 10071153

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Figure 5: Sepsis cases confirmed diagnosed at non-ASN and ASN ED sites across Alberta.

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sepsis cases confirming the premises that more cases must have been queried for sepsis during

and beyond ASN project.

Non-ASN IP and ED Sites - combined Even though query sepsis diagnosis cases were substantially lower compared to

confirmed sepsis cases, the trend between two groups remained similar. Query cases for non-

ASN sites fluctuated between 912 and 1042 between 2003 to 2010 and showed an upward

trend beyond 2010 by reaching at its highest number of 1473 in 2016 (Figure 6). This

represented a total of 59 percent increase in query sepsis cases from its base year 2010.

ASN IP and ED Sites - combined Although ASN sites showed a slightly negative trend during the pre-ASN period (less

cases were queried), query sepsis cases increased from 356 in 2010 to 632 in 2016 (Figure 7)

This represented a 77.5 percent increase in query sepsis cases at ASN sites during ASN period.

Non-ASN and ASN ED Sites Further analysis of the data also revealed that the number of query sepsis cases both for non-

ASN as well ASN ED sites changed little during 2003 to 2010 (pre-ASN period). However, the

number of query sepsis cases increased at a higher rate during ASN project period (2010 to

2016) for both ASN as well as non-ASN sits (Figure 8). For this period the increase in query

sepsis cases for non-ASN sites was 70 percent (761 to 1296), while for ASN increased 82 percent

(from 253 to 461). Additionally, a substantial proportion of the query sepsis cases came from

ED instead of IP (data not shown). The sharp increase of query sepsis cases for non-ASN ED sites

912 872

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Figure 6: Sepsis cases query diagnosed at non ASN IP and ED sites across Alberta.

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(Figure 8, solid green bars) cannot be explained, however for ASN ED (Figure 8, patterned red

bars), these cases can be attributed to added resources at ED sites as ASN funding allowed the

team to recruit staff and nurses to cover ED at some of these locations. The nurses were able to

work with ED physicians to facilitate quicker blood collection and testing.

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Figure 7: Sepsis cases query diagnosed at ASN IP and ED sites across Alberta.

Figure 8: Sepsis cases query diagnosed at non ASN and ASN ED sites across Alberta.

665 689

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Sepsis mortality rate for non-ASN and ASN sites across Alberta

The previous section showed that the number of confirmed sepsis cases as well as query

sepsis cases from ED increased during the study period of 2003 to 2016. Additionally, the

increase in sepsis cases for both categories was substantially higher during ASN project duration

of 2010 to 2016. However, the increase in sepsis cases was much higher among ASN sites than

non-ASN sites during this time. The next step is to link sepsis case diagnosis with sepsis

mortality. As one of the objectives of the ASN was to prevent sepsis related deaths by early

detection of the sepsis, it is logical to speculate that if there is an increased rate of early sepsis

diagnosis, it may translate to lower mortality rate among these subsets.

Non-ASN IP and ED Sites - combined When all the mortality data from confirmed and query sepsis cases from non-ASN IP and

ED sites was plotted, the mortality rate fluctuated initially but then dropped to 11.24 percent in

2010 (Figure 9). This represented a 1.5 percent decline in the mortality rate over this period.

Despite the fact that total number of sepsis cases for non-ASN sites increased substantially

during ASN project period (Table 1), the mortality rate for these sites changed very little. The

mortality rate changed from 11.24 percent in 2010 to 10.11 percent in 2016, an overall 10

percent decline in the mortality rate (Figure 9).

11.42 11.70 11.22 11.0912.27 12.70 13.19

11.2411.91

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Figure 9: Sepsis related mortality rates among non-ASN sites across Alberta.

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ASN IP and ED Sites - combined When the sepsis mortality data for the confirmed and query sepsis data for ASN sites

was plotted, the data revealed a different mortality outcomes for these sites. During the pre-

ASN period (2003 to 2010), the ASN sites showed a mortality decline from 15.38 percent in

2003 to 12.74 in 2010 (Figure 10). However, during ASN project (2010 to 2016) the mortality

rate for these ASN sites declined from 12.7 percent in 2010 to 8.9 percent in 2016. Using 2003

and 2010 as base years, this reduction in mortality rate translates to 17.2 percent decline for

pre-ASN (2003 to 2010) and over 30 percent decline for ASN duration (2010 to 2016). While this

decline is not massive, it may translate to over 30 lives saved in 2016 alone within these sites.

As the number of sepsis cases within non-ASN and ASN sites increased year over year,

the number of deaths increased as well. Therefore, simply using the number of deceased

patients was less useful than the mortality rate. For a reference only, the number of deceased

patients between 2002 to 2016 both for non-ASN as well as ASN sites is shown in Table 1 and

Table 2.

15.3816.1415.43

13.9313.3713.7013.4612.7412.9611.88

10.4710.99

9.04 8.90

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Figure 10: Sepsis related mortality rates across ASN sites.

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Mortality rate among confirmed sepsis cases for non-ASN and ASN sites across Alberta

In order to understand sepsis mortality and the impact of the ASN project on the

mortality rate, the data from confirmed diagnosis sepsis cases and query diagnosis sepsis cases

was separated and plotted. Since the number of confirmed diagnosis cases (particularly for

confirmed sepsis cases with ASN sites) substantially increased during ASN project, it was

expected that this would translate into reduction in mortality for these sites.

YEAR

TOTAL

Deceased

TOTAL Sepsis

related visits Deceased (%)

2003 527 4616 11.42

2004 546 4667 11.70

2005 541 4822 11.22

2006 514 4633 11.09

2007 605 4932 12.27

2008 635 4999 12.70

2009 727 5510 13.19

2010 562 4999 11.24

2011 672 5641 11.91

2012 709 6325 11.21

2013 756 6782 11.15

2014 711 6944 10.24

2015 759 7398 10.26

2016 790 7811 10.11

Total

Deceased

TOTAL

Discharged

TOTAL

Transferred

TOTAL

Admitted

Deceased

(%)

2003 292 833 198 575 15.38

2004 312 885 222 514 16.14

2005 309 847 211 635 15.43

2006 336 1052 274 750 13.93

2007 395 1131 293 1136 13.37

2008 418 1186 279 1169 13.70

2009 403 1194 286 1110 13.46

2010 383 1322 291 1011 12.74

2011 462 1469 398 1235 12.96

2012 489 1631 431 1566 11.88

2013 514 2033 474 1888 10.47

2014 561 2001 475 2066 10.99

2015 494 2235 480 2256 9.04

2016 525 2324 520 2529 8.90

Table 2: Sepsis related mortalities across non-ASN sites.

Table 1: Sepsis related mortalities across ASN sites.

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Non-ASN IP and ED Sites - combined Very little reduction in mortality rate was observed for non-ASN sites as year-over-year

mortality rates among these sites for IP and ED combined fluctuated within 1 percent during

2003 to 2016. The mortality rate reduced from 13.43 percent in 2003 to 12.80 percent in 2010

and then to 12.00 percent in 2016 (Figure 11). This translated to mere 6 percent reduction in

mortality during the project.

ASN IP and ED Sites – combined Combined mortality rates among confirmed sepsis cases at IP and ED within ASN sites

however showed a consistent decline (Figure 12). During the pre-ASN period (2003 to 2010) the

mortality declined from 18.97 percent in 2003 to 14.68 percent in 2010 (over 22 percent drop).

During the project, the mortality rates for confirmed sepsis cases across ASN sites reduced from

14.68 percent in 2010 to 10.20 percent in 2016. In contrast to non-ASN sites, this decline

represents over 30.5 percent decline in mortality rate for these sites during the project period.

For reference, the mortality data as number of deceases patients for confirmed sepsis cases for

non-ASN as well as ASN IP and ED sites is shown in Table 3 and Table 4.

13.43 13.67 13.05 13.1614.64 14.77 14.87

12.8013.91

13.09 13.0112.02 12.27 12.02

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Figure 11: Sepsis related mortality rates for confirmed sepsis cases across non-ASN IP and ED sites.

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Deceased

(Conf IP+ED)

Discharged

(Conf IP+ED)

Transferred

(Conf IP+ED)

Admitted

(Conf ED)

Deceased

(%)

2003 277 662 186 335 18.97

2004 299 685 219 328 19.53

2005 289 639 198 418 18.72

2006 321 796 245 504 17.20

2007 377 882 289 762 16.32

2008 401 967 276 805 16.37

2009 391 995 283 870 15.40

2010 369 1085 287 772 14.68

2011 444 1209 385 908 15.07

2012 473 1392 416 1176 13.68

2013 497 1757 471 1426 11.97

2014 547 1728 471 1586 12.63

2015 477 1924 461 1698 10.46

2016 504 1967 515 1956 10.20

YEAR

TOTAL

Deceased

TOTAL Sepsis

related visits

Total Deceased

(%)

2003 497 3700 13.43

2004 529 3869 13.67

2005 509 3900 13.05

2006 496 3768 13.16

2007 577 3942 14.64

2008 612 4143 14.77

2009 696 4679 14.87

2010 537 4194 12.80

2011 651 4680 13.91

2012 688 5257 13.09

2013 723 5556 13.01

2014 682 5673 12.02

2015 734 5982 12.27

2016 767 6383 12.02

18.9719.5318.72

17.2016.3216.37

15.4014.6815.0713.68

11.9712.63

10.4610.20

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2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Sep

sis

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Figure 12: Sepsis related mortality rates for confirmed sepsis cases across ASN IP and ED sites.

Table 3: Sepsis related mortalities for confirmed sepsis cases across non-ASN sites.

Table 4: Sepsis related mortalities for confirmed sepsis cases across ASN sites.

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Non-ASN and ASN IP Sites Since the largest number of confirmed sepsis cases was reported from the IP

departments for both non-ASN and ASN sites (Figure 4), it was important to look at this group

for mortality outcomes as well. When mortality data for confirmed sepsis cases for non-ASN IP

sites was separated and plotted, no major reduction in mortality change in mortality rate was

observed either pre-ASN or during the project period (Figure 13). During 2003 to 2016, percent

change in mortality rate remained under one percent.

In comparison, the mortality rate among confirmed sepsis cases at ASN IP sites showed

a decline in mortality rate during both the pre-ASN period (2003 to 2010) as well as during the

ASN project (2010 to 2016). In pre-ASN period, the mortality rate among confirmed sepsis cases

dropped from 27.17 percent in 2003 to 23.59 percent in 2010 (Figure 14); more than a 13

percent reduction in mortality rate. During the project period (2010 to 2016) ASN IP site sepsis

cases showed a higher reduction in mortality rate in comparison to the pre-project period as

well as non-ASN facilities; the mortality rate reduced from 23.59 percent in 2010 to 18.97 in

2016 (Figure 14). This translates to a 20 percent reduction in mortality rate during the ASN

period. For reference, mortality data for these confirmed sepsis cases from non-ASN and ASN IP

sites is also shown in Table 5 and Table 6.

21.96 21.32 21.03 21.45

23.75 23.93 24.45

21.7623.01 22.78 22.41

21.35 22.04 21.97

0.00

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2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

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Figure 13: Sepsis related mortality rate for confirmed sepsis cases across non-ASN IP sites in Alberta.

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27.1727.3128.26

25.6226.3425.9125.4523.5923.98

22.60

20.1921.98

18.9118.97

0.00

5.00

10.00

15.00

20.00

25.00

30.00

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Sep

sis

Mo

rtal

ity

(%)

ASN starts

YEAR

TOTAL

Deceased TOTAL Visits

Total deceased

(%)

2003 494 2250 21.96

2004 515 2416 21.32

2005 496 2358 21.03

2006 482 2247 21.45

2007 561 2362 23.75

2008 595 2486 23.93

2009 678 2773 24.45

2010 518 2380 21.76

2011 633 2751 23.01

2012 668 2932 22.78

2013 719 3208 22.41

2014 665 3115 21.35

2015 716 3248 22.04

2016 747 3400 21.97

Figure 14: Sepsis related mortality rate for confirmed sepsis cases across non-ASN IP sites in Alberta.

Table 5: Sepsis related mortalities for confirmed sepsis cases across non-ASN sites.

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Non-ASN and ASN ED Sites Although the general data for confirmed sepsis cases at non-ASN and ASN ED showed a higher

increased in sepsis cases for both non-ASN and ASN ED sites during the ASN project (Figure 5)

the mortality data for non-ASN ED remained non-conclusive (data not shown). However, the

mortality data for confirmed sepsis case at ASN ED sites showed a small but consistent decline

in mortality during the ASN period. Interestingly, the mortality rate for this group increased

from 0.45 percent in 2003 to 2.37 percent in 2010 (Figure 15). However, once the interventions

of the ASN project were initiated, the mortality rate began to decline. The mortality rate for this

group of patients in ASN sites reduced from 2.37 percent in 2010 to 0.72 percent in 2016

(Figure 15). With over 2000 admissions this translates to over 40 lives saved for 2016 alone.

This reduction in mortality may be attributed to dedicated staff for ASN ED sites. For a

reference only, mortality numbers along with discharged and admitted patients are shown in

Table 7.

Mortality rate among query sepsis cases for non-ASN and ASN sites

Similar to much of the general query diagnosis sepsis data, most of the query sepsis mortality

data for non-ASN as well as ASN IP sites was also non-conclusive particular. This may be

explained by the nature by which sepsis data was reported. Since the number of reported cases

TOTAL

Deceased

TOTAL

Discharged

TOTAL

Transferred

Deceased

(%)

2003 275 551 186 27.17

2004 298 574 219 27.31

2005 288 533 198 28.26

2006 308 649 245 25.62

2007 360 718 289 26.34

2008 377 802 276 25.91

2009 369 798 283 25.45

2010 344 827 287 23.59

2011 417 937 385 23.98

2012 452 1133 415 22.60

2013 475 1407 471 20.19

2014 523 1386 470 21.98

2015 461 1517 460 18.91

2016 487 1565 515 18.97

Table 6: Sepsis related mortalities for confirmed sepsis IP cases across ASN sites.

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across department types were not mutually exclusive, there is a possibility that patients

transitioned from query sepsis to confirmed sepsis.

0.450.23 0.19

1.961.80

2.41

2.02

2.372.24

1.441.22 1.23

0.75 0.72

0.00

0.50

1.00

1.50

2.00

2.50

3.00

3.50

4.00

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Sep

sis

Mo

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ity

(%)

ASN starts

TOTAL

Deceased

TOTAL

Discharged

TOTAL

Transferred

TOTAL

Admitted

Deceased

(%)

2003 2 111 0 335 0.45

2004 1 111 0 328 0.23

2005 1 106 0 418 0.19

2006 13 147 0 504 1.96

2007 17 164 0 762 1.80

2008 24 165 0 805 2.41

2009 22 197 0 870 2.02

2010 25 258 0 772 2.37

2011 27 272 0 908 2.24

2012 21 259 1 1176 1.44

2013 22 350 0 1426 1.22

2014 24 342 1 1586 1.23

2015 16 407 1 1698 0.75

2016 17 402 0 1956 0.72

Figure 15: Sepsis related mortality rates for confirmed sepsis cases ASN ED sites.

Table 7: Mortality rates among confirmed sepsis cases at ED sites within ASN sites.

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SUMMARY OF RESULTS

The raw sepsis data was presented in a complex manner. Several intertwined

parameters such as a lack of clarity between the mutually exclusivity or inclusivity of the data

may have posed a challenge in avoiding potential double counting. Because of this complexity,

it was difficult to analyze sepsis data or find one simple trend within the data in one particular

way. The results of the study have been shown in several possible ways in order to make best

sense of the data, find the trends, and identify the source of the trends. Categories such as

diagnosis status (confirmed vs query) and department type for both non-ASN sites as well as

ASN sites have been carefully analyzed and compared.

Sepsis diagnosis data for this study was split into two major groups (confirmed sepsis

cases and query sepsis cases) and between two department types (in-patient and Emergency

Department) for either non-ASN or ASN focused sites. The overarching aim of the ASN project

was to detect sepsis cases at an early stage and to subsequently prevent and reduce mortalities

due to sepsis. It was generally hypothesised that more sepsis cases should be either queried for

sepsis or have a confirmed diagnosis, particularly at ASN focused facilities. For this non-ASN and

ASN focused sites were compared for pre-ASN period (2003 to 2010) and for ASN project period

(2010 to 2016).

When all the confirmed and query sepsis cases from both in-patients (IP) and

Emergency Departments (ED) were plotted, there was a general upward trend in increase in the

number of sepsis cases (Figure 1) before the ASN project started and during the project period.

This rate of increase in sepsis cases was particularly higher among ASN facilities during the ASN

project timeframe (Figure 2). Further examination of the sepsis data for non-ASN and ASN sites

for confirmed sepsis cases (Figure 3) and query sepsis cases (Figure 6 and Figure 7) from IP and

ED also showed a general increase in number of cases. However, for each group of sepsis cases

the number of cases increased at a higher rate for ASN focused facilities during the ASN project

(Figure 2, Figure 3, Figure 4, Figure 5, Figure 6, Figure 7, and Figure 8). Trends in the increase in

sepsis cases during the ASN project were observed more often among IP sites than ED (except

for query diagnosis cases at both non-ASN as well as ASN ED sites – Figure 8.

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Considering ASN focused sites, sepsis mortality trends were not much different

compared to the sepsis diagnosis data trends for ASN facilities, particularly for the duration of

ASN project (2010 to 2016). While no major reduction in mortality rate was observed for non-

ASN sites across the board (Figure 9, Figure 11, and Figure 13) reduced mortality rates were

observed within ASN sites across the entire study period (2003 to 2016) and with an increased

reduction rate during the ASN project duration of 2010 to 2016 (Figure 10,Figure 12, and Figure

14). In addition, when mortality data from confirmed and query sepsis cases was separated, the

largest reduction in mortality was observed among confirmed sepsis cases for ASN focused IP

sites only (Figure 14). Most importantly, this reduction in mortality was higher during ASN

project period than the pre-project period. With the exception of confirmed sepsis cases from

ASN focused ED sites, the remaining ED mortality data as well as query sepsis mortality data

remained non-conclusive; confirmed sepsis cases for these ASN focused ED sites showed a

reduced mortality rate during ASN project period (Figure 15).

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DISCUSSION

The aging population, changing demography, lifestyles and environmental factors

(Kanavos et al 2010) have resulted in steady increase in cancers, emerging infectious diseases,

mental health issues, and cardiovascular diseases. Escalation in these disease incidences results

in personal as well as economic consequences, ultimately pushing health care costs higher.

Since health care is the single largest item in many governments’ budgets, nearly every

industrialized country, including Canada, is combating with the ever-increasing costs of health

care, and sustainability, access, and quality of their health care system is under threat.

Solving the problem of increased health care cost, an aging population and chronic

diseases is not just adding more money21 but is rooted in the improvement of health systems

through new research and development. Although the research outcomes, such as economic

benefits, overall survival, quality of life, or benefits to patients and the society, are well

documented (Krzyzanowska 2011, Salter and Martin 2001 and Zwicker and Emery 2015), the

growing concerns around the increasing cost of funding university research and the urge to

obtain value for money for public expenditure on research is not new (William 1987, OECD

1999 and Guena 1999).

A considerable amount of government and private funds are spent on research in

universities and other research facilities (UNESCO 2016),22 but even then, governments

constantly face pressure to do more. Unfortunately, the financial positions of governments are

rarely constant, and since resources are always limited, governments are faced with a range of

competing demands for funding. Distribution of these funds requires trade-offs, and not

knowing the primary economic or social rationale for the research may have left the research

sector short-changed. This, along with some of the arguments against the funding of public

science such as Reidl (2010) and Kealey (2013), triggers governments’ and policy makers’

interest in finding the evidence for or estimating the outcome and economic value of research

to the public. These outcomes and economic values are then used to make evidence-based

21 https://www.fraserinstitute.org/blogs/canadian-health-care-fix-innovation-not-more-money

22 http://unesdoc.unesco.org/images/0023/002354/235406e.pdf

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decisions so that the infrastructure required to conduct the best research is properly emplaced,

areas of interests and strengths are chosen, and nations’ competitiveness in research and

innovation can be enhanced.

Although very critical, estimating the economic value of research to the public remains

challenging. Some practitioners, such as Buxton et al (2004) state that these practical

challenges are due to the lack of direct relationship between research inputs and impact of

research or its economic value, or even defining the economic value. However, Salter and

Martin (2001) have critically reviewed and highlighted the expected economic benefits of

publicly funded research by using a range of economic studies, surveys, and case studies. In

order to measure the impact of government funded research Manton et al (2009) tracked NIH

funding from 1954 to 2004 and related it to the mortality rate from heart diseases and stroke.

The authors were able to relate positive health outcomes with the funding from NIH during this

period. Similar to this, Zwicker and Emery (2015) used a direct method by studying reduction in

mortality from potentially avoidable causes as funding in research increased. Both of the

studies are able to provide strong evidence that the public research funding has substantial

economic benefits to the system, the public, as well as direct impact on health outcomes.

This particular study is not comprehensive and does not take into the full breadth of

research funding impact, but similar to Zwicker and Emery, it looked into the impact of the

research on health outcomes using a direct method. In doing so, this study has looked at two

factors – number of sepsis patients diagnosed and the mortality rates among various patient

groups within Alberta’s IP and EDs departments. Although numbers of cases diagnosed, and

mortality rate varied over the years, the study was able to find that, not only were more sepsis

cases diagnosed during the ASN period, but mortality rates decreased among adult cases during

this project. Besides the fact that the value of lives saved is enormous, this study was not able

to put a dollar value on the return on government funding. In addition, although the ASN

contributed directly and immediately toward patients’ health outcomes, as well as toward the

direct benefits in the form of peer reviewed papers, graduate training, post graduate training

and career development for researchers and PhDs, this study did not include any payback

arising from them.

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In general, benefits or paybacks associated with spending on research for health

outcomes seems obvious to understand, benefits from public investment in research can take a

variety of forms. However, critics of the public funding of research often fail to highlight the

spillover benefits and the existence of secondary local effects in research, which are often

substantial. In the case of the ASN, although the provincial funding ended in the 6th year, the

infrastructure, multi-disciplinary team, and methodologies developed during the program are

still adding value to the research program. This enhancement in institution’s R&D capability

indeed was a huge “institutional level” success.

Besides the fact this study was able to establish a link between research and health

outcomes, this study was subject to certain methodological limitations or gaps. The

methodological limitations or gaps are highlighted in APPENDIX II and APPENDIX III).

Why government funding is important

In the eighteenth century, economist Adam Smith argued that, “The Sovereign has the

duty to maintain certain public works and certain public institutions, which can never be for the

interest of any individual because the profit could never repay the expense to any individual

though it may frequently do much more than repay it to a great society”23.

As government plays a significant role in the scientific discoveries, its role is often

understated or misrepresented. The debates around government vs private sector for who is

the real champion of innovation are often filled with a common myth that the source of

innovation is the private sector not the government. Mazzucato (2013) however has debunked

this notion by stating that, “ignoring the key state role in wealth creation creates inequality, as

it allows some hyped up actors to reap a rate of return way beyond their contribution,

therefore, it is the visible hands of the government not the invisible hand of the free market

that is responsible for the breakthrough that define these times”.

Mazzucato (2013) and Weiss (2014) further elaborated on this argument by pointing to

the famous Apple’s smartphone (iPhone), and asked if this phone would still be so smart if it

were not for the government-funded innovations (the touch screen, the GPS, the internet and

23 Taken directly from, GRAEME REID, “WHY SHOULD THE TAXPAYER FUND SCIENCE & RESEARCH.” National Centre

for Universities Business (NCUB) – 2014.

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even research behind Google) – an excellent example where risk associated to innovation are

socialized while rewards are privatized.24 The same is true for Canada as Buxton (2014)

reminded us that right at the time when the first Macintosh computer was being introduced,

the University of Toronto was well ahead in developing multi-touch screens through a Canadian

government grant in 1984.

In general, benefits associated with spending on research for health outcomes seem

obvious to understand, however benefits from public investment in research can take a variety

of forms. Salter and Martin (2001), while highlighting the expected benefits of research

investments, not only identified six economic benefits of publicly funded research but

estimated private and social rates of returns of privately funded research at 20% to 50%. In a

similar study, Hall (1993) calculated 22% as a gross rate of return on R&D in USA.

In another classical study, Mansfield (1991) sampled 76 US firms in seven industries and

reviewed 15 years of parallel academic research. He found that in the absence of academic

research 11% of the new products and 9% of new process could not have been developed

without substantial delay.

Another misconception is around the total cost of health research and its impact on the

total cost of health care. In Canada, aside from the industry support, a substantial proportion of

health research is funded by the federal and provincial governments. On a federal level, this is

done by the Tri-council25 and Canadian Fund for Innovation (CFI). 26 Although both agencies

have a varying mandate, both have made substantial contributions to the health and social

wellbeing of the Canadians by performing pivotal role in funding research. Bernstein et al

(2006), measured the impact of CIHR investments in health research and concluded that CIHR’s

investment in emerging infectious diseases during SARS breakout in 2003 helped to contain

SARS successfully.

24 Jonathan Sas, “MORE COURAGEOUS BETS AND EQUITABLE RETURNS: Challenging Perceptions about Public

Investment in Innovation.” Atkinson Foundation, (2015). http://atkinsonfoundation.ca/wp-content/uploads/2015/03/betsreturns.pdf

25 Tri-Council is comprised of Canadian Institute for Health Research (CIHR), Natural Sciences and Engineering Research Council of Canada (NSERC) and Social Sciences and Humanity Research Council of Canada (SSHRC).

26 Other agencies such as National Research Council of Canada (NRC), Western Economic Diversification, and Atlantic Canada Opportunity Agency (ACOA) also fund research.

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The CFI, a not-for-profit foundation, funds up to 40% of research infrastructure, often

conditional to the remaining 40% being matched by the province and up to 10-20% from

industry or elsewhere. An outcome measurement study for CFI by Tremblay et al (2010) found

that CFI research funding not only enhanced research capacity, highly qualified people,

research productivity and competence, but substantially contributed to innovation that helped

in the improvement of health care and enhanced products. Several other comprehensive

studies27, 28, 29 have linked Canadian international standing, health benefits, research capacity

and socio-economic benefits to the research and research funding.

In Alberta, governmental support of funded research cannot go unnoticed. Since the

creation of AHFMR in 1980 and several other Science & Technology programs,30 Alberta

remained at the forefront of building capacity (infrastructure and HQP) and performing cutting

edge research (such as ASN) for over more than two decades. During this time Alberta

remained so active in building its capacity and strengthening its academic research that by

2005, its share for the provincial R&D was 13%, while the national average was below 5%.31

However, because of provincial deficit that has been haunting Alberta since 2008, the glorious

moments for funding have disappeared. This, along with multiple restructurings of AHFMR to

AIHS to Alberta Innovates (AI), changes in its mandates, and government cut-backs32 have

created substantial anxiety among researchers and research enterprises such as universities.

Research is an expensive proposition and the burden (rather share of investment) is

often shared between national and provincial governments as well private enterprise. Since

government-sponsored research has a higher component of public good, it not only reduces the

reluctance of private sector to fund their own research but motivates them to step-up and

27 Frank, C., (2009) The Impact of Health Research. Canadian Academy of Health Sciences.

28 King, D. A., (2004) The scientific impact of nations. Nature, 430: p.311-316.

29 Ray, D., Cranston L., Sltusky A., and Feasby T. (2007) Moving at the speed of Discovery: From Bench to Bedside to Business. Report of Association of Canadian Health care Organizations.

30 Alberta Ingenuity Fund and Information Circle of Research Excellence (iCORE) to name a couple

31 Creso M. Sa´ (2010) Canadian Provinces and Public Policies for University Research. Higher Education Policy, 23, (335-357).

32 Juris Graney. Universities, school boards told to tighten belts to reduce discretionary spending. In, Edmonton Journal December 11, 2017.

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invest in R&D yielding substantially improved knowledge. This collectively results in significantly

enhanced knowledge, regional assets, targeted competitiveness, and often becomes the

source in creating a lucrative environment for other allied industries such as pharma, biotech,

and manufacturing. However, in the absence of government funding for research, private firms

may hesitate to invest in R&D and wait for others (such as government) to take the risk,

resulting in a free-rider effect giving little or no new knowledge to us. Another serious risk of

not investing in research is losing competitive advantage a nation achieves over years of hard

work and through its investments. Similar to long-term future payback of research investments,

the ugly face of lower productivity and lost competitiveness also comes long after the bad

decisions of not investing. For example, Adam (1990) suggested that 15% of economic and

production slowdown during 1970 could be related to the poor investments in research post

Second World War.

CONCLUSION AND RECOMMENDATIONS

Measuring the impact of publicly funded research is not straight forward because of the

complexity of inputs and understanding of what exactly to measure. Because of this complexity,

the researchers have not agreed upon a single gold standard method for assessing the impact

of publicly funded research. Despite these challenges, this study was able to reference

literature providing consistent evidence of direct and indirect benefits from the publicly funded

research. Collectively, all the studies happen to have a fairly common agreement that

governments’ investments in research offer a wide range of benefits that ultimately improve

innovation and save lives.

One of the notions against government funding research is its payback period. Because

of the short political cycles (often 4-8 years), political objectives and scientific objectives can

easily lead to a lack of patience among governments, the tax payers and policy makers. Short

(2-5 years) funding cycles often with little to no chance of renewal reflects the same pattern

and adds to its complexity. Right after funding expiration, all involved want to see the

immediate and tangible public benefits from the tax dollars invested in research. While doing

so, the government, critics of the funding, and public often overlook the intrinsic benefits of the

research with its future payback. Funding life cycles add further to the complexity. At the end of

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the funded project, the focus remains on the scientific merits and scientific goals as the success

factor of the project without tying them to the merits of innovation success or the innovations

success goals, if established.

In order to foster the research productivity and impact, the congruency between the

three major stakeholders - the funding agencies (government), sponsored institution, and the

researcher, play important roles. While we can argue about the impact of government funding

for health research, the philosophy for the research funding, identification of priority research

areas, as well as distribution mechanism of funds to researchers, is very complex. Although

critiquing the priority research area, funding philosophy or the methods of fund distribution is

not the scope of this study, certain recommendations33 listed below may help enhance the

impact of research in general.

• Debate about the government investing in the basic vs translational vs clinical research

is not going to end soon. Instead of competing interests, all three research areas must

be given full attention, and not at the expense of each other.

• More and more grant applications are tied to and evaluated against their practicality or

benefits to society. However, ambiguity around the “benefit to society” defined by the

funding agency (may be politically influenced) or perceived by the researchers result in

different outcomes for both. There must be a common definition of the

benefits/outcomes combined with subjective and objective parameters.

• In general, the researchers are very good in presenting their research questions

(hypothesis), elaborating how the research will be conducted, and expected results

supplemented by certain outputs (such as bibliographic and training etc.). However,

they often do not relate the outputs with outcomes or how the success will look like

for different stakeholders – an often-missing part on the evaluation of the project.

33 As this report was being written, the Minister of Science Kristy Duncan, established a nine-member advisory

panel (on Federal Support for Fundamental Research) under the leadership of David Naylor. The Panel held round table discussions, accepted over thousand written submissions, engaged 230 researchers and produced about 250-page document. The document “INVESTING IN CANDA’S FURTURE” contains an intensive environmental scan, threats and opportunities for the research in Canada. While broadly advocating for the basic research, the panel has made a score of recommendations along with a complete overhauling of the agencies and substantial increase in funding. Recommendations made through the capstone paper are more operational or policy driven.

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• Applicants should be asked to provide a detailed sustainability plan for the continuity

of the project. In general, when projects are completed, researchers move on to the

next big question for their research career with minimal to no continuity with the last

project. Often right at the end of the project, researchers and the institutions scramble

to deal with the project’s sustainability or continuity. Instead of leaving the succession

and sustainability of the research program until the end of the project, it must be an

ongoing process and part of the progressive evaluation.

• Funding for public research comes from many sources. Each of the sources, whether

public or private, is accountable for how funds are distributed, why funds are

distributed, and if the purpose of the funding is fulfilled.34 However, a stringent

accountability framework is lacking for the research community. As universities and

other public research enterprises already have a good system of financial control,

accountability, and ethical standards, the accountability mentioned here is not about

business processes but the output, outcomes and impact. Whom does the onus go to

when a project fails? How many times have the project leaders/Principle Investigators

been challenged on the project outputs and outcomes?

• Peer review is one of the most common methods used for funding allocation. Peer

review is done by the researchers and often focuses on the scientific merits. However,

post funding, neither the reviewer, nor the researchers have any accountability if the

project fails. Depending upon the mandate of the funding, the granting agencies must

incorporate other discipline to review and make final decision.

• Cost to run research enterprise is going high. It is not uncommon for a good amount of

research funding to go toward general operations of the institute, leaving less for the

actual research for which funding is provided. Institutes must foster a culture where

cost of research operation is curtailed.

• Certain grants such as CFI have higher percentage of Gift-in-Kind (GIK) from the

industry. Although GIK from the industry engages the industry and may stimulate

stronger partnership, often these partners have no urge to become part of the success

or have fear of loss if project fails. Additionally, GIKs have lower economic value for the

researchers. Government should introduce a better incentive for the industry to have

neck in the game and be part of the success or failure.

34 Naylor’s report has used word “Accountable” for 37 times, however almost every time it is used toward the

funding agencies instead of the frontline researchers.

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With the capacity to take larger risks, governments should not hesitate to invest in

research because that is what will transform the future of health. For Alberta, besides its

dynamic role and ability to create enormous wealth, Oil & Gas remains a troubling area.

Although this has tempted, rather compelled, the government to diversify Alberta’s economy,

researchers must keep educating politicians and policy makers about the value chain and

working of the science. Studies like this will help to further influence the government’s

willingness to diversify and particularly invest in health research and its allied area research.

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APPENDIX I

Key Objectives of Alberta Sepsis Network

1. Develop an integrated team of basic scientists and bedside clinicians with a purpose to

uncover the mechanisms of disease associated with sepsis, focusing on the relationship

between host innate immunity, the unique characteristics of microbes which commonly

cause severe sepsis, and the unique responses of survivors and non-survivors.

2. Development of new science and technology which will serve as the basis for first and

foremost early sepsis detection leading to a complete paradigm shift in clinical trials design.

3. An integrated clinical network of standardized care to provide optimal care of Albertans

with sepsis.

4. Infrastructure to launch clinical trials to investigate novel treatment plans in the

management of severe sepsis.

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APPENDIX II

Parameters and Limitations for Diagnostic Data

This report contains data for both confirmed and query sepsis cases for all Alberta provincial

sites that report data to AHS. Data is stratified by fiscal year (April 1 to March 31), Zone, age

category (age at time of admission/visit), whether the case was confirmed or a query diagnosis, and

by type of department (acute care - inpatient (IP), emergency room (ED) or urgent care centre

(UCC), or continuing care).

The volumes of cases are provided along with the number of unique patients. Data from

January 4, 2002 to the most current data (2016) is included. The start date for reporting varied

across facilities.

Note: Volumes reported here cannot be assumed to be mutually exclusive, or alternately,

subsets, of each other. For example, sepsis cases reported in continuing care facilities may also be

the same case(s) reported in the ED/UCC or (IP) setting. Also, cases of either a confirmed or query

sepsis diagnosis in ED/UCC cannot be assumed to be the same sepsis case in an inpatient setting; a

sepsis diagnosis in ED/UCC may be ruled out in an inpatient setting and thus not coded/captured on

the inpatient abstract. Alternately, a patient admitted through ED may not have a sepsis diagnosis

identified until later in their inpatient visit. In this case, a sepsis diagnosis would not appear on the

ED abstract, but would be coded on the inpatient record.

Inclusion criteria

Confirmed and query diagnosis sepsis cases for all facilities reporting to AHS for fiscal years

2002/03 to 2016. Also, depending on the start date of reporting, individual facilities may not

contain full fiscal year data until they have been in operation for a full fiscal year.

Exclusion Criteria:

General infection codes which did not specifically identify sepsis were not used (see

ICD10_Code_Reference tab for more details). Sites with fewer than 10 sepsis cases for the fiscal

year have been combined to comply with AHS privacy regulations.

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APPENDIX III

Parameters and Limitations for Mortality Data

This report contains mortality data for both confirmed and query sepsis cases for all Alberta

provincial sites that report data to AHS. Data is stratified by fiscal year (April 1 to March 31), Zone, age

category (age at time of admission/visit), whether the case was confirmed or a query diagnosis, and by

type of department (acute care - inpatient (IP), emergency room (ED) or urgent care centre (UCC), or

continuing care).

Patients who have a discharge disposition of "deceased" cannot be assumed to have died due to

sepsis; they had either a confirmed or query sepsis diagnosis on their abstract, but this was not

necessarily the cause of death.

Data from January 4, 2002 to the most current data (2016) is included. The start date for

reporting varied across facilities.

Note: With the exception of death cases, volumes reported here cannot be assumed to be

mutually exclusive, or alternately, subsets, of each other. For example, sepsis cases reported in

continuing care facilities may also be the same case(s) reported in the ED/UCC or (IP) setting. Also, cases

of either a confirmed or query sepsis diagnosis in ED/UCC cannot be assumed to be the same sepsis case

in an inpatient setting; a sepsis diagnosis in ED/UCC may be ruled out in an inpatient setting and thus not

coded/captured on the inpatient abstract. Alternately, a patient admitted through ED may not have a

sepsis diagnosis identified until later in their inpatient visit. In this case, a sepsis diagnosis would not

appear on the ED abstract, but would be coded on the inpatient record.

A patient may have had prior visits/admissions in which they were discharged alive, and the

same patient may have returned for a later visit/admission and had a discharge disposition of

'Deceased'.

Inclusion Criteria

Confirmed and query diagnosis sepsis cases for all facilities reporting to AHS for fiscal years

2002/03 to 2016. Also, depending on the start date of reporting, individual facilities may not contain full

fiscal year data until they have been in operation for a full fiscal year.

Exclusion Criteria

Confirmed and query diagnosis sepsis cases for all facilities reporting to AHS for fiscal years

2002/03 to 2016. Also, depending on the start date of reporting, individual facilities may not contain full

fiscal year data until they have been in operation for a full fiscal year.

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