‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature

Mairéad Finn; Lisa Mellon; Aisling Walsh; Niall O'Brien; David J. Williams; Natasha Rafter; Siobhán E. McCarthy

doi:10.12688/hrbopenres.13576.2

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Revised

‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature

[version 2; peer review: 2 approved, 1 approved with reservations]

Mairéad Finn ¹, Lisa Mellon², Aisling Walsh², [...] Niall O'Brien³, David J. Williams⁴, Natasha Rafter², Siobhán E. McCarthy¹

Mairéad Finn ¹, Lisa Mellon², [...] Aisling Walsh², Niall O'Brien³, David J. Williams⁴, Natasha Rafter², Siobhán E. McCarthy¹

PUBLISHED 18 Nov 2022

Author details Author details

¹ Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland
² Department of Public Health and Epidemiology, RCSI University of Medicine and Health Sciences, Dublin, Ireland
³ Library Services, RCSI University of Medicine and Health Sciences, Dublin, Ireland
⁴ Department of Geriatric and Stroke Medicine, RCSI University of Medicine and Health Sciences, Dublin, Ireland

Mairéad Finn
Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Lisa Mellon
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Aisling Walsh
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Niall O'Brien
Roles: Data Curation, Methodology, Project Administration, Software

David J. Williams
Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing

Natasha Rafter
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

Siobhán E. McCarthy
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Introduction: Interventions designed to improve safety culture in hospitals foster organisational environments that prevent patient safety events and support organisational and staff learning when events do occur. A safety culture supports the required health workforce behaviours and norms that enable safe patient care, and the well-being of patients and staff. The impact of safety culture interventions on staff perceptions of safety culture and patient outcomes has been established. To-date, however, there is no common understanding of what staff outcomes are associated with interventions to improve safety culture and what staff outcomes should be measured.
Objectives: The study seeks to examine the effect of safety culture interventions on staff in hospital settings, globally.
Methods and Analysis: A mixed methods systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches will be conducted using the electronic databases of MEDLINE, EMBASE, CINAHL, Health Business Elite, and Scopus. Returns will be screened in Covidence according to inclusion and exclusion criteria. The mixed-methods appraisal tool (MMAT) will be used as a quality assessment tool. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials and non-randomised studies of interventions will be employed to verify bias. Synthesis will follow the Joanna Briggs Institute methodological guidance for mixed methods reviews, which recommends a convergent approach to synthesis and integration.
Discussion: This systematic review will contribute to the international evidence on how interventions to improve safety culture may support staff outcomes and how such interventions may be appropriately designed and implemented.

Keywords

patient safety, safety culture, hospital setting, healthcare worker, management

Corresponding author: Mairéad Finn

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board [APA – 2019 - 024].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2022 Finn M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Finn M, Mellon L, Walsh A et al. ‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature [version 2; peer review: 2 approved, 1 approved with reservations]. HRB Open Res 2022, 5:48 (https://doi.org/10.12688/hrbopenres.13576.2) First published: 01 Jul 2022, 5:48 (https://doi.org/10.12688/hrbopenres.13576.1) Latest published: 18 Nov 2022, 5:48 (https://doi.org/10.12688/hrbopenres.13576.2)

Revised Amendments from Version 1

A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

See the authors' detailed response to the review by Jane K. O'Hara
See the authors' detailed response to the review by Laura Adamson

Introduction

In 2000, the seminal report by the Institute of Medicine, To Err is Human, estimated over 90,000 patient deaths from medical error related to both system failure and poor organisational culture¹. Since that time the incidence of patient safety events have remained high globally, due in part to the increasing complexity of healthcare and multi-morbidities^2,3. To Err is Human recommended the concept of a patient safety culture to support the health workforce to provide safer care^1,4. A major focus is on the reduction and mitigation of patient safety events, building a culture of reporting and learning from events, and supporting those affected by harm. Patients are considered first victims of patient safety events, while members of the workforce may experience a second victim impact, including physical and psychological distress^5,6. How organisations respond to and learn from safety events affecting patients, families and staff is a marker of their patient safety culture and impacts the future safety and wellbeing of all concerned.

A safety culture is about shared organisational beliefs, values, norms and procedures for patient safety^7,8. Safety climate, on the other hand, relates to a group or team perception of safety culture in organisations⁹. Rather than a specific process or technology, interventions to promote a culture of safety are designed to improve organisational conditions, enhancing leadership and teamwork among health care providers to support safe patient care^10–12. Safety culture interventions which target staff behaviour include executive walk-rounds or interdisciplinary rounds; multicomponent unit-based interventions; team training or communication initiatives¹¹; frameworks for assessing, reporting and improving patient safety concerns; and standalone courses^13,14. Patient safety educational interventions have also targeted the patient safety skills, attitudes and knowledge of healthcare workers to support safe patient care¹⁵, with safety culture likely moderating their impact¹⁶. While there are over 80 definitions of the terms “safety culture”, “patient safety culture” and “safety climate” across the literature¹⁷, core distinctions are set out in Table 1.

Table 1. Definitions and terms.

Patient safety culture	One aspect of an organization’s culture. It can be personified by shared values, beliefs, norms, and procedures related to patient safety among members of an organization, unit, or team. It influences clinician and staff behaviours, attitudes, and cognitions through cues about the relative priority of patient safety compared to other goals such as throughput or efficiency¹¹.
Safety culture	The product of individual and group values, attitudes, perceptions, competencies, and patterns of behaviour that determine the commitment to, and the style and proficiency of, an organisation’s health and safety management⁴.
Safety climate	Group or team perceptions of safety culture in organisations. These are measurable aspects of safety culture, in contrast to domains of culture such as behaviour and values⁹.

The theoretical construct of “safety culture” is contested in the literature¹⁸. One perspective posits that safety culture exists as an empirical measurable entity, as a product of values, beliefs, attitudes and behaviours, to be manipulated by intervening in the healthcare system⁴. A contrasting perspective views the concept of safety culture more usefully deployed as a conceptual lens to inform analysis of the healthcare system¹⁸. In the latter, safety behaviours are a reflection of a generic organisational culture, emerging over time through other multiple internal and external system dynamics¹⁹. The dearth of robust, definitive explanations for changes in safety culture in the literature, particularly those that demonstrate little connection between safety culture interventions and reduced adverse events, is seen as supporting the conceptual approach¹⁹.

The empirical assessment of safety culture is also diverse, with multiple tools based on unique constructs of safety culture¹⁷. Furthermore, there is increased recognition of the need for triangulated data sources to assess the safety of healthcare organisations. Data on safety culture alone is not always considered sufficient to explain changes in safety behaviours and culture^19,20. Additional data sources such as routine hospital data on adverse events, and multiple types of data such as quantitative and qualitative are needed to better inform analysis19. Recently, Churrucca et al. constructed common over-arching themes to synthesise domains of safety culture across different assessment tools17. These common themes enable comparison between various data collection instruments17.

Reflecting the above debates, evidence on the effectiveness of interventions to improve safety culture is weak, but suggests they contribute to clinical care processes and to improved clinician and staff perceptions of safety culture¹¹. A safety culture can support staff to deliver effective and timely care to patients, increase staff competencies to collectively learn from patient safety events when they occur²¹, and can strengthen organisational support to healthcare teams to recover from patient safety events^22–26. Despite a focus on patient safety within measures of safety culture, there is inconsistent evidence for the link between interventions seeking to enhance a safety culture and patient outcomes such as hospital readmission rates, length of stay, pressure ulcers and falls, or ventilator associated pneumonia^15,27–31. The knowledge base on safety culture and patient outcomes is mixed, and a safety culture can moderate the effects of patient safety interventions on patients.

Measures of safety culture focus on staff attitudes and behaviours related to the prioritisation of patient safety^4,32,33. In hospitals, evaluations of safety culture typically measure workforce related domains such as teamwork, communication, or information exchange, safety culture outcomes such as reporting rates, and patient outcomes such as falls, length of stay, or readmission rates^11,27. A minority of measures include domains related to staff outcomes such as staff safety behaviours, staff injury rates, or well-being following a patient safety event³⁴. Interventions to enhance safety culture are generally targeted at enhancing the norms and behaviours of hospital staff, but without an associated focus or exploration of the staff outcomes associated with safety culture. Evidence suggests that a safety culture can alleviate stress and burnout for staff^35–37, support recovery and learning from events, and safeguard against repeat events^38–41 by supporting staff to safely speak out about what is not working^34,42. There is a now a need for a review of the impact of safety culture interventions on staff, to generate a common understanding of what staff outcomes are associated with interventions to improve safety culture and what staff outcomes should be measured. This research seeks to isolate staff outcomes, thereby examining the impact of safety culture interventions on staff where staff effects are claimed to take place.

Safety culture measurement tools focus on generating data to improve the safety of care provided to patients, and they do so by measuring staff perceptions of safety culture⁴³, including staff attitudes, behaviours, and norms¹⁷. Depending on the instruments selected, staff outcomes and experiences may be captured through the deployment of safety culture measurement tools alone or in combination with other data sources. Prior research suggests a bi-directional relationship between safety culture and staff experience. The strongest evidence suggests that a safety culture influences certain staff outcomes such as staff behaviour to improve safety, event reporting, staff turnover, and injury rates among staff^34,44. This literature reviews seeks to isolate staff outcomes as the point of interest including, but not limited to, burnout, stress, well-being, turnover or absenteeism^36,45. In doing this, the review recognises studies that claim to manipulate safety culture.

Hospital staff experiences of and outcomes from interventions to improve safety culture are rarely examined in their own right. There is a knowledge gap on how safety culture affects staff in hospital settings. This systematic review seeks to address the knowledge gap and generate a conceptual understanding of associated staff outcomes based on the available published evidence, evaluating the state of evidence connecting safety culture to staff outcomes. Understanding these issues is important: as Shaw et al. have stated, ‘there is no patient safety without health worker safety’⁴⁶.

Systematic review aims and objectives

A systematic review of the literature will examine the state of evidence connecting interventions to improve safety culture to hospital staff outcomes. The research questions are:

1) How is safety culture defined in studies with interventions that aim to enhance it?
2) What effects do interventions to improve safety culture have on hospital staff?
3) What intervention features, safety culture domains or other factors explain these effects?
4) What staff outcomes and experiences are identified?

Design

This study is a mixed methods systematic review^47,48 of published literature guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines⁴⁹.

Methods

Search strategy

Searches will be conducted using the electronic databases of MEDLINE, EMBASE, CINAHL, Health Business Elite, and Scopus. The search strategy will include the following terms: patient safety culture, hospital workforce and management, hospital setting, and high-, middle- and low-income countries. The primary search will begin in PUBMED with major keywords listed on the Medline Medical Subject Headings (MeSH) terms, such as “patient safety,” “safety climate,” and “hospital workforce”. Search terms will be used in conjunction with Boolean Operators “AND” and “OR.” Supplementary Files will provide details of the full search strategy. Reference lists of all articles included for full-text screening will also be searched. A sample of the search run through Medline is provided in Table 2.

Table 2. Search strategy.

Keyword	Related terms/synonyms
Intervention	(safety OR quality OR organisation* OR just OR learning OR no-blame) N2 (culture OR climate OR attitude OR patient OR support OR management OR improvement OR enhancement) N2 (intervention OR initiative OR strategy) OR ((MH "Patient Safety") OR (MH "Safety+) AND (MH "Patients+")) AND ((MH "Quality Improvement+") OR (MH "Organizational Culture"))
Context	(health OR acute OR hospital) N2 (care OR center* OR centre* OR setting OR environment OR department OR division* OR facilit* OR team* OR unit*) OR (MH "Hospitals+")
Population	(administrat* OR allied OR auxiliary OR clinical OR frontline OR health* OR hospital OR licensed OR manager OR management OR medical OR nurs* OR operations OR social OR support OR trained OR welfare) N2 (aide* OR agent* OR assistant* OR attendant* OR auxiliar* OR carer* OR caregiver* OR consultant* OR distributor* OR individual* OR mentor* OR officer* OR person OR personnel OR practitioner* OR profession* OR professional* OR promotor* OR provider* OR service* OR staff OR surveyor* OR therap* OR worker) OR (clinician OR counselor* OR counsellor* OR doctor* OR doula* OR “general practitioner” OR hospitalist OR midwi* OR nurse* OR paraprofessional* N2 health* OR physician* OR physiotherapist OR psychotherapist* OR therapist* OR pharmacist*) OR (MH "Health Personnel+")
Outcome	performance OR outcome OR burnout OR stress OR satisfaction OR improv* OR well-being OR second victim OR report* OR working conditions OR behavior OR turnover OR injury rates OR problem solving OR safety competenc* OR recover* OR skill OR attitude OR knowledge OR trust OR learn*
*is used to signify truncation

Inclusion and exclusion criteria

Articles that report research involving both clinical and non-clinical members of the hospital workforce, and hospital management, will be included. Articles will be included if they are (a) quantitative, qualitative or mixed methods studies that evaluate an intervention in a hospital setting with an explicit aim to improve safety culture; (b) contain empirical data for analysis; (c) are available in any language; (d) are published in peer-reviewed scholarly journals; and (e) are published since 2000 (from the publication date of To Err is Human).

Articles will be excluded if they (a) describe interventions that do not have an explicit aim to improve safety culture, (b) do not measure the effect of the intervention on safety culture, and/or (c) have a primary purpose other than hospital staff or patient safety culture. From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings. Inclusion and exclusion criteria are illustrated in Table 3.

Table 3. Systematic review inclusion and exclusion criteria.

	Inclusion criteria	Exclusion criteria
Population	Hospital health care workers, including clinical, non-clinical and management staff.	Primary or Specialist Care
Intervention	Intervention studies designed to improve safety culture that include an explicit measure of safety culture.	Descriptions of safety culture interventions without any measures or outcomes captured.
Context	Hospitals Global: high-, middle-, and low-income country	Non-Hospital Settings
Outcome	Staff related safety culture outcomes and experiences that are identified following a hospital based intervention to improve safety culture.	Safety Culture Outcomes, Safety Climate Outcomes, or Patient Outcomes with no distinction of staff outcomes or experiences.
Date range	Published from 2000	Published before 2000
Publication Type	Research Article	Conference Abstracts, Conference Proceedings, Grey Literature, Reports
Languages	All

Article review process

Search results will be entered to Endnote where duplicates will be removed. Titles and abstracts of remaining articles will be screened for inclusion by two reviewers in Covidence, a systematic review data management program. Disagreement will be resolved by discussion with a third reviewer. Those selected for full-text review will be assessed according to the inclusion and criteria for addition to the final sample, again by two reviewers and discussion with a third to resolve disagreements.

Data extraction and quality assessment

Data will be extracted from each article and organized into a matrix. The articles will be examined to determine if and how well they measure effect on or capture outcome experience of health care workers and management following safety culture interventions. Data will be organised according to author, year, sample size, sample characteristics, place of publication, study setting, study design, intervention structure, intervention content, intervention duration, outcomes measured, measurement instrument, and principal findings. Data from included articles will be assessed independently by two authors, and disagreements will be resolved by discussion until a consensus is reached. The mixed-methods appraisal tool (MMAT) will be used as a quality assessment tool, with two authors discussing and cross-checking quality scores^49–51. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials⁵² and non-randomised studies of interventions⁵³ will be employed to verify bias.

Data synthesis and analysis

Synthesis will follow the Joanna Briggs Institute methodological guidance for mixed methods reviews, which recommends a convergent approach to synthesis and integration⁴⁸ following the work of Hong et al.,⁵⁰ and Sandelowski⁵¹. A convergent integrated approach, with simultaneous synthesis, is suitable as the review question can be answered by both quantitative and qualitative research designs, involves data transformation and allows reviewers to combine quantitative and qualitative data⁴⁸. To answer the research questions ‘how is safety culture defined in studies with interventions that aim to enhance it.?’; ‘what effects do interventions to improve safety culture have on staff?’; ‘what intervention features, safety culture domains or other factors explain these effects?’, and ‘what staff outcomes and experiences are identified?’ a thematic analysis of staff outcomes will be simultaneously combined with data on measures and effects available in the evidence.

Study status

Preliminary searches and study selection process piloted. We are currently formally screening search results against eligibility criteria.

Data availability

No data are associated with this article.

Faculty Opinions recommended

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Version 2

VERSION 2 PUBLISHED 01 Jul 2022

Author details Author details

Lisa Mellon
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Aisling Walsh
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Validation, Writing – Review & Editing

Niall O'Brien
Roles: Data Curation, Methodology, Project Administration, Software

David J. Williams
Roles: Conceptualization, Funding Acquisition, Methodology, Writing – Review & Editing

Natasha Rafter
Roles: Conceptualization, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

Siobhán E. McCarthy
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Supervision, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Health Research Board [APA – 2019 - 024].
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

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Published: 18 Nov 2022, 5:48

https://doi.org/10.12688/hrbopenres.13576.2

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https://doi.org/10.12688/hrbopenres.13576.1

© 2022 Finn M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Finn M, Mellon L, Walsh A et al. ‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature [version 2; peer review: 2 approved, 1 approved with reservations]. HRB Open Res 2022, 5:48 (https://doi.org/10.12688/hrbopenres.13576.2)

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ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Version 2

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PUBLISHED 18 Nov 2022

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Reviewer Report 19 Jul 2023

Ward Schrooten, Department of Medicine and Life Sciences, Hasselt University, Hasselt, Flanders, Belgium

Marlies Claesen, Department of Medicine and Life Sciences, Hasselt University, Hasselt, Flanders, Belgium

Approved

https://doi.org/10.21956/hrbopenres.14928.r34743

The introduction provides different perspectives on the definition of safety culture and refers to the various domains of safety culture used in safety culture measurement tools. The focus of this systematic review is introduced.
The aims and objectives of the study are clearly stated.
The methods section explains the search strategy, inclusion and exclusion criteria, article review process, data extraction and quality assessment, and data synthesis and analysis. Tables 2 and 3 provide further detail.
This study protocol describes an appropriate study design for the research question and sufficient detail to allow replication by others.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Outcome assessment, Clinical epidemiology, Quality and safety, Population health

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report 24 Nov 2022

Laura Adamson, Department of Radiation Oncology, Sydney West Radiation Oncology Network, Crown Princess Mary Cancer Centre, Sydney, NSW, Australia

Approved

https://doi.org/10.21956/hrbopenres.14928.r33209

No ... Continue reading

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VERSION 1

PUBLISHED 01 Jul 2022

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Reviewer Report 18 Oct 2022

Laura Adamson, Department of Radiation Oncology, Sydney West Radiation Oncology Network, Crown Princess Mary Cancer Centre, Sydney, NSW, Australia

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14825.r33029

Thank you for the opportunity to review this protocol to perform a mixed methods systematic review on healthcare worker staff outcomes of safety culture interventions.

The study protocol is clear. The rationale for investigating the gap in the literature is well stated and supported. I anticipate that there will be a variety of interventions, and safety culture assessments across the literature.

Some minor comments and recommendations:

With multiple safety culture measurement tools within in the literature, the authors should ensure they note the disparity between the tools. Consideration will be needed when comparing the different assessment tools and the authors should avoid direct comparison. I wonder if any additional questions around what measurement tools of safety culture are currently used.
The authors state that the Lancet has stated "xxx" in a sentence, however it is not the Lancet, but the author that has published in the Lancet, that has stated that this sentence should be corrected to Shaw et al. or similar stated.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Incident learning systems and safety culture in Radiation Oncology.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

21 Feb 2023

Author Response

Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add ... Continue reading Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Laura Adamson:

Thank you for these observations. We are collating findings as per the individual survey domains and then collating these to common high level narrative themes as developed by Churruca et al. (https://bmjopen.bmj.com/content/11/7/e043982). This is not for direct comparison but rather to enable a high level integrated narrative on the studies included. Churruca et al used these successfully in a recent systematic review of tools. Please see below extract to make clear to reader:

“A recent development has been the development by Churruca and colleagues of common over-arching thematic labels to bring together and describe the domains of safety culture across different assessment tools. While tools are not directly comparable, these common themes make high level comparsions more amenable.”

Thank you also for noting the point on authorship in the Lancet publication: amended as detailed.
Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Laura Adamson:

Thank you for these observations. We are collating findings as per the individual survey domains and then collating these to common high level narrative themes as developed by Churruca et al. (https://bmjopen.bmj.com/content/11/7/e043982). This is not for direct comparison but rather to enable a high level integrated narrative on the studies included. Churruca et al used these successfully in a recent systematic review of tools. Please see below extract to make clear to reader:

“A recent development has been the development by Churruca and colleagues of common over-arching thematic labels to bring together and describe the domains of safety culture across different assessment tools. While tools are not directly comparable, these common themes make high level comparsions more amenable.”

Thank you also for noting the point on authorship in the Lancet publication: amended as detailed.
Competing Interests: There are no competing interests. Close
Report a concern
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COMMENTS ON THIS REPORT

Author Response 21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

21 Feb 2023

Author Response

Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add ... Continue reading Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Laura Adamson:

Thank you for these observations. We are collating findings as per the individual survey domains and then collating these to common high level narrative themes as developed by Churruca et al. (https://bmjopen.bmj.com/content/11/7/e043982). This is not for direct comparison but rather to enable a high level integrated narrative on the studies included. Churruca et al used these successfully in a recent systematic review of tools. Please see below extract to make clear to reader:

“A recent development has been the development by Churruca and colleagues of common over-arching thematic labels to bring together and describe the domains of safety culture across different assessment tools. While tools are not directly comparable, these common themes make high level comparsions more amenable.”

Thank you also for noting the point on authorship in the Lancet publication: amended as detailed.
Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Laura Adamson:

Thank you for these observations. We are collating findings as per the individual survey domains and then collating these to common high level narrative themes as developed by Churruca et al. (https://bmjopen.bmj.com/content/11/7/e043982). This is not for direct comparison but rather to enable a high level integrated narrative on the studies included. Churruca et al used these successfully in a recent systematic review of tools. Please see below extract to make clear to reader:

“A recent development has been the development by Churruca and colleagues of common over-arching thematic labels to bring together and describe the domains of safety culture across different assessment tools. While tools are not directly comparable, these common themes make high level comparsions more amenable.”

Thank you also for noting the point on authorship in the Lancet publication: amended as detailed.
Competing Interests: There are no competing interests. Close
Report a concern

Views

Reviewer Report 22 Aug 2022

Jane K. O'Hara, NIHR Yorkshire and Humber Patient Safety Translational Research Centre, Bradford, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14825.r32559

Thank you for the opportunity to review this article. I found it generally clear and well argued. Whilst there have been many reviews on general safety culture, and patient safety culture, this does seem to add to this already large literature by focusing explicitly on the relationship between interventions and the impact on staff outcomes. I applaud the authors for taking on such a review, as I can imagine that actually working through the papers, with their likely vast array of different types of interventions and definitions of safety culture, will be a significant undertaking.
I do have a few comments and suggestions for the authors to consider in their revisions.

Is the rationale for, and objectives of, the study clearly described?

The paper clearly describes a set of research questions. However, I do have a couple of queries for the authors on the scope of the questions. The term safety culture is contested within academia and practice. The authors describe some of this variation in the term in their rationale, but I think they could, and perhaps should reflect this a little more in the body of their introduction. This is particularly important given that there is an implicit assumption embedded in this type of review (exploring the impact of an intervention on an outcome) that the construct that is foundational to the intervention can be manipulated, therefore leading to some change in the outcome. In the context of safety culture, there are some authors that would argue that it cannot be manipulated, but rather is an emergent property of a system – an outcome of other processes and structures – or at the very least, bidirectional (as the authors themselves mention). Of course, we can’t be sure what position is ‘right’ but I do think the authors need to be clear that the manipulation of culture is in itself contested, and that by doing the review, they are taking an explicit position on this discussion. A good commentator on this issue is Stian Antonsen - I would urge the authors to engage in his work in this paper and the subsequent final review.
In terms of the research questions, because of this disagreement within the field I wonder if the review would benefit from an explicit research question about the nature of the definition of safety culture contained within studies looking to manipulate it?
Is the study design appropriate for the research question?

Largely, I think the design is appropriate. However, I do have a slight concern about the exclusion of research that does not present an explicit measure of safety culture as part of the intervention. This would exclude papers reporting research that is based broadly on the position that improving safety culture or facets of safety culture (including all of the varied ways that culture is conceived – for example, team communications and team working) might lead to improvements in an outcome of interest, but that don’t undertake measurement of ‘safety culture’. This in and of itself is not necessarily a problem, but I think the authors need to be clear the impact this will have on the review and the findings. It is also likely to exclude most qualitative work, which from my reading of the methods is included in the review.
Are sufficient details of the methods provided to allow replication by others?

Yes.
Are the datasets clearly presented in a useable and accessible format?

The databases to be reviewed are stated clearly.

General comments:

Just a small, perhaps pedantic, point. At the end of the rationale, the authors state:
“Understanding these issues is important: as the Lancet has stated, ‘there is no patient safety without health worker safety’⁴³."
The Lancet did not state this; rather, the authors who were published in The Lancet said that within that particular paper.
There are a couple of typographical errors in the manuscript – perhaps editorial could attend to these?

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

CITE

Report a concern

Author Response 21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

21 Feb 2023

Author Response

Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add ... Continue reading Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Jane O'Hara:
Thank you for these welcome observations. Drawing on the work of Stian Antonsen, in our introduction we have further developed varying theoretical approaches to the understanding and investigation of safety culture. We draw attention to differing approaches and acknowledge the specific focus of our research question relates to studies that view safety culture as manipulable (see also inclusion and exclusion criteria). We will clarify that no one position is right and be clear that the manipulation of culture is in itself contested, and that by doing the review, we are focusing on studies that take an explicit position on this discussion. Our position aligns to studies that seek to measure changes to culture in a system, though we do not argue this is ‘right’.

Furthermore, we have since conducted the search and know now the variations in scale and time frame of included studies. For example, one study conducted a 3-year long intervention to influence culture. Several interventions were multi-pronged across long time frames. We will discuss these findings in the final review.

We have added a research question on the definitions of safety culture contained within the included studies: “How is safety culture defined in studies with interventions that aim to enhance it.” We will record these and any theory of change documented in the included studies.

We have made both the explicit focus and limitation of our study more clear to readers. In the section on inclusion and exclusion criteria, we include the statement: “From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings.”

Thank you for identifying the correct authorship within the Lancet publication, we will amend.
Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Jane O'Hara:
Thank you for these welcome observations. Drawing on the work of Stian Antonsen, in our introduction we have further developed varying theoretical approaches to the understanding and investigation of safety culture. We draw attention to differing approaches and acknowledge the specific focus of our research question relates to studies that view safety culture as manipulable (see also inclusion and exclusion criteria). We will clarify that no one position is right and be clear that the manipulation of culture is in itself contested, and that by doing the review, we are focusing on studies that take an explicit position on this discussion. Our position aligns to studies that seek to measure changes to culture in a system, though we do not argue this is ‘right’.

Furthermore, we have since conducted the search and know now the variations in scale and time frame of included studies. For example, one study conducted a 3-year long intervention to influence culture. Several interventions were multi-pronged across long time frames. We will discuss these findings in the final review.

We have added a research question on the definitions of safety culture contained within the included studies: “How is safety culture defined in studies with interventions that aim to enhance it.” We will record these and any theory of change documented in the included studies.

We have made both the explicit focus and limitation of our study more clear to readers. In the section on inclusion and exclusion criteria, we include the statement: “From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings.”

Thank you for identifying the correct authorship within the Lancet publication, we will amend.
Competing Interests: There are no competing interests. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

21 Feb 2023

Author Response

Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add ... Continue reading Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Jane O'Hara:
Thank you for these welcome observations. Drawing on the work of Stian Antonsen, in our introduction we have further developed varying theoretical approaches to the understanding and investigation of safety culture. We draw attention to differing approaches and acknowledge the specific focus of our research question relates to studies that view safety culture as manipulable (see also inclusion and exclusion criteria). We will clarify that no one position is right and be clear that the manipulation of culture is in itself contested, and that by doing the review, we are focusing on studies that take an explicit position on this discussion. Our position aligns to studies that seek to measure changes to culture in a system, though we do not argue this is ‘right’.

Furthermore, we have since conducted the search and know now the variations in scale and time frame of included studies. For example, one study conducted a 3-year long intervention to influence culture. Several interventions were multi-pronged across long time frames. We will discuss these findings in the final review.

We have added a research question on the definitions of safety culture contained within the included studies: “How is safety culture defined in studies with interventions that aim to enhance it.” We will record these and any theory of change documented in the included studies.

We have made both the explicit focus and limitation of our study more clear to readers. In the section on inclusion and exclusion criteria, we include the statement: “From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings.”

Thank you for identifying the correct authorship within the Lancet publication, we will amend.
Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Jane O'Hara:
Thank you for these welcome observations. Drawing on the work of Stian Antonsen, in our introduction we have further developed varying theoretical approaches to the understanding and investigation of safety culture. We draw attention to differing approaches and acknowledge the specific focus of our research question relates to studies that view safety culture as manipulable (see also inclusion and exclusion criteria). We will clarify that no one position is right and be clear that the manipulation of culture is in itself contested, and that by doing the review, we are focusing on studies that take an explicit position on this discussion. Our position aligns to studies that seek to measure changes to culture in a system, though we do not argue this is ‘right’.

Furthermore, we have since conducted the search and know now the variations in scale and time frame of included studies. For example, one study conducted a 3-year long intervention to influence culture. Several interventions were multi-pronged across long time frames. We will discuss these findings in the final review.

We have added a research question on the definitions of safety culture contained within the included studies: “How is safety culture defined in studies with interventions that aim to enhance it.” We will record these and any theory of change documented in the included studies.

We have made both the explicit focus and limitation of our study more clear to readers. In the section on inclusion and exclusion criteria, we include the statement: “From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings.”

Thank you for identifying the correct authorship within the Lancet publication, we will amend.
Competing Interests: There are no competing interests. Close
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Version 2

VERSION 2 PUBLISHED 01 Jul 2022

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Jane K. O'Hara, NIHR Yorkshire and Humber Patient Safety Translational Research Centre, Bradford, UK
Laura Adamson, Crown Princess Mary Cancer Centre, Sydney, Australia
Ward Schrooten, Hasselt University, Hasselt, Belgium

Marlies Claesen, Hasselt University, Hasselt, Belgium

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19 Jul 2023 | for Version 2

Ward Schrooten, Department of Medicine and Life Sciences, Hasselt University, Hasselt, Flanders, Belgium

Marlies Claesen, Department of Medicine and Life Sciences, Hasselt University, Hasselt, Flanders, Belgium

25 Views Cite this report Responses(0)

Approved

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Outcome assessment, Clinical epidemiology, Quality and safety, Population health

We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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34 Views

24 Nov 2022 | for Version 2

Laura Adamson, Department of Radiation Oncology, Sydney West Radiation Oncology Network, Crown Princess Mary Cancer Centre, Sydney, NSW, Australia

34 Views Cite this report Responses(0)

Approved

No further comment.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Incident learning systems and safety culture in Radiation Oncology.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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37 Views

18 Oct 2022 | for Version 1

Laura Adamson, Department of Radiation Oncology, Sydney West Radiation Oncology Network, Crown Princess Mary Cancer Centre, Sydney, NSW, Australia

37 Views Cite this report Responses(1)

Approved With Reservations

With multiple safety culture measurement tools within in the literature, the authors should ensure they note the disparity between the tools. Consideration will be needed when comparing the different assessment tools and the authors should avoid direct comparison. I wonder if any additional questions around what measurement tools of safety culture are currently used.
The authors state that the Lancet has stated "xxx" in a sentence, however it is not the Lancet, but the author that has published in the Lancet, that has stated that this sentence should be corrected to Shaw et al. or similar stated.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Incident learning systems and safety culture in Radiation Oncology.

Respond to this report

Responses (1)

Author Response

21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

View more View less

Competing Interests

There are no competing interests.

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Reviewer Report

54 Views

22 Aug 2022 | for Version 1

Jane K. O'Hara, NIHR Yorkshire and Humber Patient Safety Translational Research Centre, Bradford, UK

54 Views Cite this report Responses(1)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

The paper clearly describes a set of research questions. However, I do have a couple of queries for the authors on the scope of the questions. The term safety culture is contested within academia and practice. The authors describe some of this variation in the term in their rationale, but I think they could, and perhaps should reflect this a little more in the body of their introduction. This is particularly important given that there is an implicit assumption embedded in this type of review (exploring the impact of an intervention on an outcome) that the construct that is foundational to the intervention can be manipulated, therefore leading to some change in the outcome. In the context of safety culture, there are some authors that would argue that it cannot be manipulated, but rather is an emergent property of a system – an outcome of other processes and structures – or at the very least, bidirectional (as the authors themselves mention). Of course, we can’t be sure what position is ‘right’ but I do think the authors need to be clear that the manipulation of culture is in itself contested, and that by doing the review, they are taking an explicit position on this discussion. A good commentator on this issue is Stian Antonsen - I would urge the authors to engage in his work in this paper and the subsequent final review.
In terms of the research questions, because of this disagreement within the field I wonder if the review would benefit from an explicit research question about the nature of the definition of safety culture contained within studies looking to manipulate it?
Is the study design appropriate for the research question?

Largely, I think the design is appropriate. However, I do have a slight concern about the exclusion of research that does not present an explicit measure of safety culture as part of the intervention. This would exclude papers reporting research that is based broadly on the position that improving safety culture or facets of safety culture (including all of the varied ways that culture is conceived – for example, team communications and team working) might lead to improvements in an outcome of interest, but that don’t undertake measurement of ‘safety culture’. This in and of itself is not necessarily a problem, but I think the authors need to be clear the impact this will have on the review and the findings. It is also likely to exclude most qualitative work, which from my reading of the methods is included in the review.
Are sufficient details of the methods provided to allow replication by others?

Yes.
Are the datasets clearly presented in a useable and accessible format?

The databases to be reviewed are stated clearly.

General comments:

Just a small, perhaps pedantic, point. At the end of the rationale, the authors state:
“Understanding these issues is important: as the Lancet has stated, ‘there is no patient safety without health worker safety’⁴³."
The Lancet did not state this; rather, the authors who were published in The Lancet said that within that particular paper.
There are a couple of typographical errors in the manuscript – perhaps editorial could attend to these?

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Respond to this report

Responses (1)

Author Response

21 Feb 2023

Mairéad Finn, Graduate School of Healthcare Management, RCSI University of Medicine and Health Sciences, Dublin, Ireland

Thank you to both reviewers for the time and reflection taken to appraise this work. Their feedback greatly enhances the piece and we are grateful for the opportunity to add clarity and further investigate the literature. A short summary of our updates is: an enhanced review of the deployment of safety culture as a concept, and the differing perspectives therein; an incorporation of the new research question recommended; a clarification on the specific focus and limitation of the research; clarification on the treatment of varying measurement instruments in the review; and an adjustment to the reference in the Lancet, as observed by both reviewers.

Jane O'Hara:
Thank you for these welcome observations. Drawing on the work of Stian Antonsen, in our introduction we have further developed varying theoretical approaches to the understanding and investigation of safety culture. We draw attention to differing approaches and acknowledge the specific focus of our research question relates to studies that view safety culture as manipulable (see also inclusion and exclusion criteria). We will clarify that no one position is right and be clear that the manipulation of culture is in itself contested, and that by doing the review, we are focusing on studies that take an explicit position on this discussion. Our position aligns to studies that seek to measure changes to culture in a system, though we do not argue this is ‘right’.

Furthermore, we have since conducted the search and know now the variations in scale and time frame of included studies. For example, one study conducted a 3-year long intervention to influence culture. Several interventions were multi-pronged across long time frames. We will discuss these findings in the final review.

We have added a research question on the definitions of safety culture contained within the included studies: “How is safety culture defined in studies with interventions that aim to enhance it.” We will record these and any theory of change documented in the included studies.

We have made both the explicit focus and limitation of our study more clear to readers. In the section on inclusion and exclusion criteria, we include the statement: “From a theoretical perspective, the research approach may limit the review to studies that view safety culture as amenable to change within a healthcare system, and exclude conceptual studies. The approach adopted is an explicit focus limited to studies that seek to measure change in safety culture as a totality and not sub-elements of safety-culture only. Limitations of the study design, such as bias toward quantitative studies and interventions which target safety culture will be acknowledged in the findings.”

Thank you for identifying the correct authorship within the Lancet publication, we will amend.

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Competing Interests

There are no competing interests.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Table 1. Definitions and terms.

Systematic review aims and objectives

Design

Methods

Search strategy

Table 2. Search strategy.

Inclusion and exclusion criteria

Table 3. Systematic review inclusion and exclusion criteria.

Article review process

Data extraction and quality assessment

Data synthesis and analysis

Study status

Data availability

References

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‘What effect do safety culture interventions have on health care workers in hospital settings?’ A systematic review of the international literature

Abstract

Keywords

Revised Amendments from Version 1

Introduction

Table 1. Definitions and terms.

Systematic review aims and objectives

Design

Methods

Search strategy

Table 2. Search strategy.

Inclusion and exclusion criteria

Table 3. Systematic review inclusion and exclusion criteria.

Article review process

Data extraction and quality assessment

Data synthesis and analysis

Study status

Data availability

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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