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Abstract
Introduction To our knowledge, this study is the first to identify and describe current sepsis policies, clinical practice guidelines, and health professional training standards in Canada to inform evidence-based policy recommendations.
Methods and analysis This study will be designed and reported according to the Arksey and O’Malley framework for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched for policies, clinical practice guidelines and health professional training standards published or updated in 2010 onwards, and related to the identification, management or reporting of sepsis in Canada. Additional sources of evidence will be identified by searching the websites of Canadian organisations responsible for regulating the training of healthcare professionals and reporting health outcomes. All potentially eligible sources of evidence will be reviewed for inclusion, followed by data extraction, independently and in duplicate. The included policies will be collated and summarised to inform future evidence-based sepsis policy recommendations.
Ethics and dissemination The proposed study does not require ethics approval. The results of the study will be submitted for publication in a peer-reviewed journal and presented at local, national and international forums.
- Health policy
- Protocols & guidelines
- INTENSIVE & CRITICAL CARE
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STRENGTHS AND LIMITATIONS OF THIS STUDY
A diverse group of individuals were involved in the design of this study, including clinician scientists, policy experts, individuals with lived sepsis experience and members of the Sepsis Canada leadership team.
Multiple sources of evidence, including peer-reviewed sources and the websites of organisations responsible for regulating the training of healthcare professionals and reporting health outcomes, in both English and French, will be reviewed.
Only policies, guidelines and standards that are applicable in Canada will be included.
Introduction
Sepsis is defined as life-threatening organ dysfunction caused by the dysregulated host response to an infection.1 In 2017, an estimated of 48.9 million incident cases and 11 million sepsis-related deaths were reported worldwide, representing approximately 20% of all global deaths.2 Many of those who survive sepsis are left with long-term disability and have an increased risk of rehospitalisation and death.3–5 The healthcare costs for sepsis are significant. In Ontario alone, sepsis costs are estimated to exceed one billion dollars.6 To date, clinical studies on sepsis have focused on establishing consensus on the pathogenesis and treatment of sepsis.7 However, in 80% of cases, the onset of sepsis occurs outside healthcare settings, highlighting the need for public health and policy measures to reduce infection rates and improve early detection in the emergency department.8
In 2013, after the death of a 12-year-old boy due to sepsis, New York State Governor Andrew Cuomo passed ‘Rory’s Regulations’, which require all New York hospitals to develop protocols for early identification and treatment of sepsis.9 Specifically, according to Title 10 of the New York State Codes, Rules and Regulations (sections 405.2 and 405.4), acute care hospitals in New York are required to (1) adopt and implement evidence-based protocols for early recognition and treatment of sepsis; (2) train staff to appropriately implement sepsis protocols and (3) collect and report quality measures related to recognition and treatment of sepsis for internal quality measurements and reporting to the New York Department of Health. Included in ‘Rory’s Regulations’ is a Parents’ Bill of Rights that seeks to improve paediatric sepsis care, including timely communication of key tests and lab results.
Rory’s Regulations were the first example of state-mandated regulations for sepsis in the USA. Other states, including Illinois in 2016 and New Jersey in 2018, have implemented similar regulations. In 2018, 15 other states implemented strategies to reduce the burden of sepsis.10 11 The implementation of national sepsis policies, guidelines and clinical standards has been associated with a reduction in sepsis mortality in other countries. SEPSIS KILLS, an Australian quality improvement programme aimed at improving the recognition and treatment of sepsis, has been associated with reduced sepsis-related mortality and improved outcomes in emergency departments in New South Wales.12 Similarly, a UK study found an association between the implementation of sepsis treatment pathways, including the Sepsis Six care standard and reduced mortality.13 In Ireland, there was an observed 60% increase in the recognition and documentation of sepsis cases following the implementation of the Irish National Clinical Guideline No. 26 outlining sepsis management for adults.14 Despite the reported improvement in sepsis mortality in New York, the implementation of sepsis-related legislation in other states, and similar policies around the world, there is no similar sepsis policy in Canada.15 16 To our knowledge, this will be the first study to analyse the current landscape of sepsis policies, clinical practice guidelines and health professional training standards to inform future policy directions in Canada.
Aims and objectives
This study is part of a larger initiative, led by Sepsis Canada, to inform evidence-based recommendations on sepsis policy and training standards in Canada. In this first phase, we aim to (1) identify and describe existing sepsis policies, clinical practice guidelines and health professional training standards in Canada and (2) highlight potential threats and opportunities to sepsis policy development to inform evidence-based policy recommendations.
Methods and analysis
This review will be conducted according to the stages outlined by Arksey and O’Malley and Levac et al. These stages include (1) identifying the research question, (2) identifying relevant studies, (3) study selection, (4) charting the data, (5) collating, summarising and reporting the results and (6) consultation.17 18 The proposed study will be reported using the criteria identified by the Preferred Reporting Items for Systematic Review and Meta-analyses Extension for Scoping Reviews guidelines19 and registered on Open Science Framework (https://osf.io/), prior to beginning the review.
Environmental scanning methodology, identified as an effective public health tool to inform policy, will be adapted to systematically identify data sources not typically published in peer-reviewed journals.20 The environmental scan method is appropriate when sources of evidence span several mediums.
Stage 1: identification of the research question
This scoping review aims to answer the following question: ‘what are the current sepsis policies, clinical practice guidelines and health professional training standards in Canada?’. Our research question was intentionally designed with a broad scope to include the wide-ranging sources of evidence and types of policies related to sepsis. For this review, any sepsis policy, guideline or training standard related to sepsis identification, management and/or reporting will be included.
Stage 2: identification of relevant sources of evidence
A comprehensive search strategy was developed in collaboration with an experienced health librarian and informed by multiple stakeholders, including clinician scientists, health researchers and patient partners, to identify peer-reviewed studies (online supplemental appendix 1). Databases including EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched from 2010 to January 2024, and the selection of studies will be limited to studies available in English or French. The references of all included studies and any identified reviews will be searched to identify additional articles for inclusion. The search strategy will be adapted to each database as needed.
Supplemental material
To identify data sources not typically published in peer-reviewed journals, including training standards, we will start by compiling a list of Canadian organisations responsible for regulating the training of healthcare professionals and organisations responsible for reporting health outcomes at the provincial and national levels. A preliminary list of organisations can be found in table 1. This list was informed by the Sepsis Canada Policy Working Group, which includes healthcare professionals, patient partners, policy experts and individuals with expertise in health professional education, and will be iteratively updated to ensure comprehensiveness. Each organisation’s website will then be independently searched for language that mentions infection and/or sepsis recognition and treatment, included in policy documents, training modules or resources, curriculum documents, reporting standards and accreditation standards.
Preliminary list of organisations to identify sepsis policies, guidelines and standards
Stage 3: selection of sources of evidence
To pilot test the inclusion/exclusion criteria, a random selection of 10 articles identified in the search will be independently reviewed by at least two reviewers for inclusion. Discrepancies between reviewers and any changes in inclusion/exclusion criteria will be discussed with the study team. References from the updated search will be uploaded to Covidence (Veritas Health Innovation, Melbourne, Australia) for screening. Following training and calibration, reviewers will screen (1) the title and abstracts of all studies identified in the literature search and (2) the full-text articles of studies identified as potentially eligible by at least one author in the title and abstract screening phase.
Additional policy resources identified through organisation websites will also be screened by two reviewers prior to inclusion in the final review. The reasons for exclusion following full document review will be recorded. Discrepancies between reviewers will be resolved by discussion with the independent investigator or the larger working group, as needed.
Eligibility
Studies, policies, guidelines and standards will be eligible for inclusion if they (1) have been published or revised since 2010; (2) report on policies, guidelines or standards specific to the identification, management and/or reporting of sepsis in Canada; (3) are publicly available or easily accessible through a reasonable request and (4) are available in English or French. Studies or policy resources published prior to 2010 will be excluded, as this review aims to provide an overview of the current landscape. Commentaries on sepsis policies, policies that apply to areas outside of Canada, and policies that are superseded by more relevant policies will be excluded.
Stage 4: data charting
For studies, policies, guidelines and standards that meet the eligibility criteria, we will extract (1) bibliographic details (eg, author, title, date of publication); (2) the names of the organisation(s)/stakeholder(s) involved in the development and the authoritative or regulatory body and (3) information on the policy, guideline or standard, including policy type, jurisdiction or setting in which the policy/guideline applies, target patient population, whether it includes reportable information either to a government organisation and/or public reporting, date since last updated, and which sepsis definition it corresponds to. Specific to policies and training standards, where bibliographic and other details may not be available or reported differently, we will also extract aims, the impetus/origin, and measures of inclusive authorship (ie, whether individuals with lived experience were included or not).
We will pilot test the data abstraction form in a random sample of eligible articles, and any disagreements between reviewers during the pilot and full abstraction phases will be resolved by discussion with the independent investigator. At least two studies or policy resources from each source of evidence will be used to pilot the data abstraction form to ensure good inter-rater reliability.
An initial list of variables to be extracted is shown in table 2.
Preliminary data extraction form
Stage 5: collating, summarising and reporting the results
To guide the reporting of the included sources of evidence, sources will be classified as pertaining to the identification, management or reporting of sepsis. Bibliographic details, information on each of the policies, guidelines, and standards, and the authoritative or regulatory bodies involved will be collated and summarised in tables.
We will use the framework method, a type of qualitative content analysis, to guide the narrative synthesis.21 22 The framework method is a systematic and flexible approach to qualitatively analysing large amounts of data and is appropriate for multidisciplinary teams engaging in qualitative analysis.21 The framework method consists of the following stages (1) familiarisation with the source of evidence; (2) coding; (3) development and application of an analytical framework; (4) collating and summarising the data and (5) interpreting the data. In applying this approach, we aim to draw descriptive conclusions on the current landscape of sepsis policies, guidelines and standards in Canada.
In the narrative synthesis, we will also identify the gaps and limitations in existing policies and opportunities to address identified gaps. Consistent with the objectives of this review, no statistical analyses will be performed.
Stage 6: consultation
We will consult individuals with lived sepsis experience, including those who are part of the Sepsis Canada Policy Working Group and the larger Patient Advisory Council, to inform the design of this study and the interpretation of the results. This will ensure that the scope, reporting of the results and subsequent policy recommendations reflect the values and perspectives of those who have experienced sepsis.
Ethics and dissemination
The proposed study is a scoping review with no requirement for ethics approval. The results of this study will be disseminated through peer-reviewed publication, presentations at local, national and international conferences, on social media (eg, Twitter) and through selected engagement with relevant policy stakeholders.
Ethics statements
Patient consent for publication
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Twitter @fatima_sheikkh, @kristinerussell, @drfoxrob
Contributors FS and KB conceptualised and designed the study with input from LS and AF-R. VC, ND, NK, GEG, KH, NK, OL and KR provided additional guidance and input. FS drafted the protocol manuscript. All authors provided feedback throughout and reviewed the final draft of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests GG is an employee of the Canadian Medical Protective Association. LS is funded by the Arnold L. Johnson Chair in Health Care Ethics, an endowed Chair at McMaster University. AFR is the Scientific Director of Sepsis Canada, a CIHR-funded network. KB has consulted for Fresenius Medical Care.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.