The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol

Anne Marie Keown; Seán Paul Teeling; Martin McNamara

doi:10.12688/hrbopenres.13933.1

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Study Protocol

The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol

[version 1; peer review: 2 approved]

Anne Marie Keown¹, Seán Paul Teeling ^1,2, Martin McNamara¹

PUBLISHED 13 Aug 2024

Author details Author details

¹ UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland
² Centre for Person-Centered Practice Research,Division of Nursing, School of Health Sciences, Queen Margaret University Drive, Queen Margaret University, EH21 6UU Musselburgh, UK

Anne Marie Keown
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Seán Paul Teeling
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Martin McNamara
Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Global healthcare faces challenges such as rising costs, budget constraints, aging populations, chronic diseases, and increasing patient expectations. Healthcare organisations are deploying continuous improvement methodologies to address these challenges. Lean, derived from the Toyota Production System, focuses on eliminating non-value-adding activity and enhancing efficiency, making it a prominent quality improvement approach in healthcare. Effective implementation of Lean requires robust leadership to sustain improvements and foster a culture of continuous improvement. However, the attributes, values, principles, and behaviours of effective Lean leaders in healthcare remain underexplored.

Methods

This realist review protocol details methods to research how leaders' and managers' attributes, values, principles, and behaviours contribute to the sustainable implementation of Lean in healthcare. Following the RAMESES guidelines, a five-stage structured methodology will be used: defining the scope of the review and developing initial theories, developing the search strategy, reviewing primary studies and extracting data, synthesising evidence and developing conclusions, refining theory iteratively, and disseminating findings. An Expert Panel and reference groups of healthcare managers and leaders will refine candidate programme theories (CPTs) into initial programme theories (IPTs), guiding detailed evidence searches and data extraction.

Conclusion

This realist review will deepen our understanding of the specific mechanisms by which leadership impacts Lean implementation outcomes in the context of acute hospitals. By exploring how leadership attributes, values, principles and behaviours shape outcomes for diverse stakeholders, the review aims to provide critical insights into the dynamics driving the success of Lean in healthcare. The findings will inform policy and practice, enhancing leadership strategies to improve patient and staff experiences, patient outcomes, and organizational performance.

Keywords

Realist Review, Protocol, Leadership, Lean, Improvement, Healthcare.

Corresponding author: Seán Paul Teeling

Competing interests: No competing interests were disclosed.

Grant information: Health Research Board Ireland CES-2024-037.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2024 Keown AM 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: Keown AM, Teeling SP and McNamara M. The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol [version 1; peer review: 2 approved]. HRB Open Res 2024, 7:54 (https://doi.org/10.12688/hrbopenres.13933.1) First published: 13 Aug 2024, 7:54 (https://doi.org/10.12688/hrbopenres.13933.1) Latest published: 13 Aug 2024, 7:54 (https://doi.org/10.12688/hrbopenres.13933.1)

Introduction

Global healthcare is experiencing significant disruption due to rising care costs, budget constraints, ageing populations, chronic diseases, and increasing patient expectations. These challenges necessitate innovative approaches to improve performance^1–3. It has been argued that this requires new leadership and management strategies¹. An analysis of 30 years of service reorganisation in Ireland, concluded that effective and sustainable change requires not only incremental improvements but also innovative transformations in care delivery and leadership practices⁴. Recent studies^4–6 highlight that traditional leadership approaches are insufficient for the complexities of modern healthcare.

Continuous improvement

In response to these complexities, Quality Improvement (QI) methodologies like Lean, Six Sigma, and Lean Six Sigma (LSS) have been used for continuous improvement and have shown to be effective for enhancing organisational efficiency and ensuring high-quality patient care^7,8. A survey by the University of California, Berkeley found nearly 70% of US healthcare systems engaged in improvement initiatives such as Lean thinking¹. However, only 12% of hospitals reported mature, hospital-wide implementation, highlighting the need for leadership commitment and daily management systems¹.

Aligning improvement methodologies with health system priorities and developing a shared culture of problem-solving, driven by leadership commitment has been promoted⁹. Lean has emerged as a globally recognised management improvement paradigm, extending beyond manufacturing to various sectors, including healthcare¹⁰.

Lean in healthcare

Lean, derived from the Toyota Production System (TPS), focuses on eliminating activities that do not add value to a process to improve the flow of people, information, or goods^11,12. Initially popularised by Womack¹³, Lean aims to increase care quality and efficiency¹⁴. It has become a dominant quality improvement approach in healthcare literature, emphasising the need for an organisational strategy that integrates Lean principles, culture, and focused leadership¹⁵. Effective Lean implementation in healthcare requires system-wide change and strong leadership to sustain improvements¹⁶. Leadership is crucial for creating a continuous improvement culture, empowering frontline staff, and aligning organisational values and behaviours with Lean principles^12,17.

Lean leadership

Lean leadership is essential for the sustainable integration of Lean in healthcare, focusing on values, respect, consensus on behaviours, and a no-blame culture¹⁸. Successful Lean leaders foster a culture of collaboration, problem-solving, and continuous improvement¹⁹. Despite its importance, the specific attributes and behaviours of effective Lean leaders in healthcare are not well-defined in the literature^20–22. Understanding the attributes, behaviours, values, and principles of Lean leadership is crucial for effective Lean deployment and strategic healthcare management. This protocol paper outlines a realist review of literature that forms part of a wider realist inquiry that aims to explore these aspects, addressing the gap in scholarly understanding of Lean leadership in healthcare.

Use of realist inquiry

Given the low maturity of Lean leadership as a scientific topic, literature reviews are scarce and often treat it as a secondary theme²³. The risk of attributing causal power to healthcare leadership for the outcomes of Lean systems without clarity on the constructs and causal mechanisms involved has been highlighted¹⁹. Current definitions of Lean leadership lack a theoretical basis related to general leadership theories, leading to unclear rationales and divergent aspects. Existing research has not addressed the causal mechanisms by which leadership behaviours influence Lean implementation^19,24. The complexity and context-dependence of Lean leadership behaviours in healthcare make this a subject well-suited to realist inquiry.

Pawson argues that realism serves as a methodological framework guiding various research methods²⁵. Bhaskar's work positions realist inquiry within the broader realist philosophy of science and social science, emphasising the identification of generative causation through underlying causal mechanisms²⁶. Realist inquiry aims to understand "what works, for whom, under what circumstances, and why"^12,25,27,28. Realist inquiry comprises realist review and realist evaluation²⁵. Realist review (or synthesis) examines existing data or stakeholder perspectives, while realist evaluation involves primary research with direct data collection. This approach has been widely used in healthcare and is growing in popularity for evaluating Lean healthcare interventions^12,28,29.

Realist inquiry goes beyond exploring surface-level inputs and outputs by discerning how the resources of a specific intervention or programme evoke and interact with stakeholders’ psychosocial responses, and mechanisms (M) that trigger intervention outcomes (O) in specific contexts (C)³⁰. Researchers develop a Context-Mechanism-Outcome (CMO) hypothesis to predict which mechanisms operate in different contexts and the resulting outcomes³¹. This configuration is ideal for exploring the context-sensitivity of leaders’ behaviours and the contextual factors impacting Lean implementation in healthcare. It can be applied to Lean leadership in specific contexts (C) to investigate what resources it provides and what responses these resources evoke (M), that generate observed outcomes (O).

Protocol

The realist review outlined in this protocol seeks to understand how and under what circumstances the attributes, values, principles, and behaviours of leaders and managers contribute to the sustainable implementation of Lean in healthcare settings. This review will explore the specific mechanisms by which leaders' practices, impact implementation outcomes both anticipated and unanticipated in various contexts. Leadership behaviours may affect different groups, including frontline staff, middle managers, and senior executives, in distinct ways³². By investigating how leadership attributes and behaviours shape outcomes for these diverse stakeholders, this review aims to deepen our understanding of the dynamics that drive the success of Lean implementation in healthcare. In doing so, it will offer critical insights into how leadership and contextual factors interact to influence the effectiveness of Lean methodologies.

The research question guiding the realist review described in this protocol is outlined below:

• In acute hospital settings where staff are trained in Lean and it is implemented as an improvement methodology, what are the specific attributes, values, principles, and behaviours of Lean leaders and managers, and how do the mechanisms these activate along a continuum for different stakeholder groups impact the anticipated outcome of sustainable Lean deployment?

Methods

A realist review interprets existing data through a realist approach applied to retrospective literature reviews³³. This method acknowledges that theories may not always predict outcomes across all contexts³⁴. Realist reviews have been described as explanatory and non-judgmental, iteratively testing and building theory³⁵. The RAMESES guidelines provide standards to improve the rigor and comparability of realist and meta-narrative reviews³⁶. A five-stage structured methodology consistent with the RAMESES guidelines has been developed³⁷ which we have utilised to inform this review:

1. Define the scope of the review and develop initial theories.

2. Develop the search strategy.

3. Review primary studies and extract data.

4. Synthesise evidence and develop conclusions.

5. Refine theory iteratively and disseminate findings.

1. Define the scope of the review and develop initial theories

The development of candidate programme theories (CPTs) in a realist review provides a framework for analysing interventions' causal mechanisms that generate the outcome of an intervention in specific contexts²⁸. Developing CPTs involves mapping out potential explanations of how the intervention works. This theoretical mapping typically draws on a scoping review of existing literature, expert insights, and preliminary data, forming a hypothesis about the intervention’s mechanisms³⁸.

The realist review described in this protocol focuses on theories explaining how leadership behaviours and attributes influence the sustainability of Lean implementation in healthcare. The identification of relevant theories for the realist review began with a preliminary scoping search. A preliminary background search in key databases was undertaken searching by titles of articles, abstracts, keywords, and subject headings to guide the development of the CPTs. Consultation with a university librarian enhanced the strategy, ensuring both breadth and depth in the search³⁹ and leading to the use of the largest medical and nursing databases, (Medline, EMBASE, Emerald, EBSCO, CINAHL). The searches included combinations of the keywords (Lean, Six Sigma, Leadership, healthcare, behaviours, attributes, and implementation). Searches yielded a number of articles (n=24) directly and fully related to the research question which contributed to the development of CPT. The initial scoping search, while not exhaustive, was foundational to constructing the review through the development of candidate programme theories (CPTs), crucial for understanding complex interventions.

As CPT are in effect ‘rough’ theories, they provide a beginning framework that is expected to evolve as evidence is gathered and analysed⁴⁰. Consultations with reference groups of healthcare managers and leaders who spearheaded Lean deployment further informed the development of CPTs for this study. These consultations sought perspectives on contexts, mechanisms, and outcomes of sustainable Lean deployments. Combined with the scoping literature search and team discussions, this developed six CPTs for expert panel review (additional material 1).

Expert panels, comprising practitioners, researchers, and theorists, refine programme theories, ensuring alignment with theoretical expectations and practical realities through rigorous scrutiny and cross-disciplinary validation⁴¹. They guide researchers to key literature, assess evidence quality, and interpret complex data, enhancing the review's credibility and acceptance. For this review, an expert panel of Lean experts from academia and practice in Europe, the United States, and Australia has been convened.

2. Develop the search strategy

Consistent with realist methodology, the expert panel will confirm, refute, or refine the 6 CPT⁴⁰ and identify what, in their experience, facilitates or hinders the effectiveness of the intervention (in this case Lean deployment) to deliver anticipated outcomes⁴². This will further develop the CPTs to Initial Programme Theories (IPTs) which congruent with realist methods, will inform a detailed evidence search based on keywords from these IPTs⁴³. Developing an effective search strategy is crucial for a comprehensive realist review, capturing a broad evidence base to uncover complex phenomena through mechanisms and contextual factors. Initially, broad search terms derived from the IPTs will be used, aligning with PRISMA guidelines for systematic reviews⁴⁴ and RAMESES guidelines for realist reviews³⁵.

The search will use multiple sources, supported by a librarian, including internet search engines, electronic databases, and literature citing the included papers, references within those papers, relevant grey literature, and organizational websites. Suggestions from the expert panel will also be incorporated to ensure comprehensive coverage. The inclusion and exclusion criteria for the literature review will be systematically outlined using the PICOC (Population, Intervention, Comparison, Outcome, Context) framework⁴⁵ which facilitates structuring research questions and defining criteria, crucial for capturing the full scope of the evidence and understanding complex phenomena⁴⁶.

The criteria in Table 1 were generated after developing the CPTs and will be refined as the review progresses. This iterative approach will ensure a thorough literature exploration, progressively refining the intervention's theoretical framework. This process allows ongoing refinement based on emerging evidence and expert feedback^12,28. The search strategy will facilitate the identification of specific mechanisms and outcomes, enhancing the rigour and depth of the realist review.

Table 1. PICOC used to clarify inclusion and exclusion criteria.

PICOC Element	Key concept	Inclusion and exclusion criteria
Population	Leaders in healthcare organisations (acute hospitals, systems) who are at a mature stage of implementing Lean.	Included: Healthcare organisations (acute hospitals) hospital systems, that have adopted Lean healthcare improvement interventions to a mature stage characterised by sustained improvement, strong leadership commitment, established daily management systems, data-driven decision-making, staff engagement, and empowerment. This stage is typically reached in 5–10 years after initial implementation⁴⁷ Excluded: Healthcare organisations that do not meet this inclusion criterion. Excluded: Non-acute healthcare organisations that do not meet this inclusion criterion (Primary Care, mental health specialist services).
Interventions	Lean leadership (behaviors, attributes, values, principles)	Included: Leading lean improvement interventions Excluded: Other quality improvement interventions
Comparison	Other QI methodologies	Included: Lean methodology. Excluded: Other QI methodologies. For consideration: Whether other QI methodologies mentioned as comparators in the retrieved literature (e.g., combined use of Lean and Six Sigma) will be included where relevant to the research question.
Outcomes	Sustained/ successful implementation adoption of Lean. Culture of continuous improvement.	Included: The study will look for evidence of how leadership attributes behaviours, values, and principles have contributed or not contributed to the sustainable implementation of Lean improvement in these settings. Included: The study will look for evidence of how leaders in these settings have supported lean implementation by demonstrating key behaviours.
Context	Time Language Setting	The time frame for the consideration of studies will be from 2000 to 2026. Healthcare organisations, organisations delivering services to hospitals. English Acute Hospitals/ acute health systems

3. Review primary studies and extract data

Documents retrieved will be selected for their relevance to the research question⁴⁷ and their contribution to the development of IPTs^25,28. Small sections of a primary study can be relevant when testing specific hypotheses about context, mechanisms, and outcomes⁴⁸. These documents will form a robust collection of papers, essential for a theory-driven realist review to further refine the IPTs⁴⁹.

The selection of studies hinges on relevance and rigour. Relevance is assessed by whether a study can contribute to building or testing a programme theory, while rigour refers to the credibility of the methods used to collect the data^34,50. These criteria will guide the inclusion or exclusion of literature in the review⁵¹. Data extraction involves three steps: initial screening by title and abstract, full-text retrieval, and appraisal. Titles and abstracts will be reviewed in duplicate by Authors 1 and 2 using predefined criteria (Table 1). Documents passing this stage will be assessed for richness and rigour by Author 3. Discrepancies will be resolved through discussion among all three authors, adhering to RAMESES guidelines³⁴. To facilitate data extraction, bespoke forms will be developed, tailored to the theoretical framework of the review⁵². Standardised forms may be unsuitable; hence, tailored forms will capture contextual factors, mechanisms, and outcomes relevant to the research question⁵³.

4. Synthesize evidence and develop conclusions

After data extraction, papers will be imported into NVivo⁵⁴, version 14 (Mac) a specialised qualitative software widely used in realist reviews for coding and thematic analysis to identify Context-Mechanism-Outcome Configurations (CMOCs) which is available freely to students and faculty within UCD. Leaders from healthcare organisations at the forefront of Lean deployment will be re-engaged to refine the theoretical framework, contributing their expertise. Review stages will be revisited as needed to ensure comprehensive data collection and achieve theory saturation. Refined initial program theories (IPTs) from the realist review will then be presented to an expert panel for adjudication and feedback, ensuring robustness, contextual sensitivity, and reflection of intervention complexities^34,52.

5. Refine theory iteratively and disseminate findings

The refined Initial Programme Theories (IPTs) derived from the realist review will undergo iterative evaluation and feedback from the expert panel to ensure accurate interpretation of results²⁵. This engagement with the expert panel aims to enhance the robustness, contextual sensitivity, and comprehensive reflection of the inherent complexities in the intervention's implementation and outcomes³⁵.

The outcomes of this realist review will follow RAMESES reporting guidelines⁵³ and will be disseminated through peer-reviewed journal publications, conference presentations to healthcare and academic audiences, and engagement with key stakeholders. Additionally, findings will be integrated into a PhD thesis. This review sets the foundation for a subsequent realist evaluation involving healthcare leaders experienced in Lean implementation whose organisation are at a mature stage of Lean deployment. This realist review protocol is undergoing review by the PROSPERO Editorial committee and we will provide a protocol registration number when this is completed.

Ethics

Ethical approval is not needed because this study is a synthesis of published literature and no data collection will take place.

Conclusion

The realist review outlined in this protocol aims to explore Lean leadership within the healthcare sector, investigating its role in addressing the challenges of sustainably deploying Lean methodologies in acute healthcare organisations. Existing literature highlights the importance of effective leadership in sustaining Lean initiatives, fostering continuous improvement, and achieving operational excellence^1,19,20. Realist inquiry is ideal for this investigation as it comprehensively explores contextual factors, causal mechanisms, and outcomes related to Lean leadership in healthcare⁵⁵.

This approach identifies not only effective strategies but also the underlying reasons and conditions influencing their success, providing a robust framework for understanding causal mechanisms in complex organisational contexts⁴⁰. It seeks detailed insights into the attributes and behaviours that characterise effective Lean leadership, significantly contributing to the scholarly understanding of Lean leadership in healthcare¹⁹. The study aims to offer practical implications for healthcare management and leadership development, enhancing knowledge of how Lean leadership-attributes, values, principles and behaviours can improve patient and staff experiences, patient outcomes, and organisational performance²⁰. Ultimately, this research will inform policy and practice, ensuring effective implementation and sustainability of Lean leadership strategies in healthcare settings.

Systematic review registration

This protocol is currently undergoing review by the PROSPERO Editorial committee and registration number will be added as soon as available.

Ethics

Ethical approval is not needed because this study is a synthesis of published literature and no data collection will take place.

Consent to participate

This is a protocol paper so not applicable.

Data availability

Underlying data

No data are associated with this article

Extended data

Figshare: Whether, to what extent, and in what circumstances and ways do leaders’ and managers’ attributes, values, principles and behaviours contribute to the sustainable implementation of Lean in healthcare.

Teeling, Sean Paul (2024). Prisma -P checklist for Realist Review Protocol. figshare. Dataset. https://doi.org/10.6084/m9.figshare.26212916⁵⁶

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0)

Teeling, Sean Paul (2024). Additional data File 1 CPT.docx. figshare. Dataset. https://doi.org/10.6084/m9.figshare.26212862.v3⁵⁷

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0)

Acknowledgments

We acknowledge the valuable contributions of our local reference groups and expert panels, whose insights and expertise have been instrumental in guiding and refining this research.

Faculty Opinions recommended

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56. Teeling SP: Prisma-P checklist for realist review protocol. figshare. Dataset. 2024. http://www.doi.org/10.6084/m9.figshare.26212916
57. Teeling SP: Additional data File 1 CPT.docx. figshare. Dataset. 2024. http://www.doi.org/10.6084/m9.figshare.26212862.v3

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Version 1

VERSION 1 PUBLISHED 13 Aug 2024

Author details Author details

Anne Marie Keown
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Martin McNamara
Roles: Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

Health Research Board Ireland CES-2024-037.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (1)

version 1

Published: 13 Aug 2024, 7:54

https://doi.org/10.12688/hrbopenres.13933.1

© 2024 Keown AM 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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Keown AM, Teeling SP and McNamara M. The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol [version 1; peer review: 2 approved]. HRB Open Res 2024, 7:54 (https://doi.org/10.12688/hrbopenres.13933.1)

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Reviewer Report 31 Jan 2025

Rebecca Hardwick, University of Plymouth, Plymouth, UK

Approved

https://doi.org/10.21956/hrbopenres.15288.r43324

This paper sets out a process for surfacing the underlying mechanisms that drive leadership of lean interventions in healthcare. It proposes using a realist review methodology to develop context, mechanism outcome explanations of how sustainability of lean outcomes are achieved by leadership behaviours.

The study rationale and objectives, and research question are clear and appropriate, and the study design is an excellent choice for interrogating these issues. Whilst I have said that the study design and methods are clearly laid out to allow replication from others, this is not a necessary mark of quality in realist reviews - programme theory building and refining is an interpretative process, and does not follow the usual rules for traditional systematic review in this way - I think the authors know this though, and no changes need to be made.

My only query is why the inclusion criteria is focusing on acute hospitals alone - whilst logical in some respects, including other health care (or indeed wider, such as VCSE settings) where Lean has been implemented may yield very useful information to further refine programme theory: my question is, what else might be learnt from including other settings? In realist work, context is more than 'place' or geography, but is really about that which supports or inhibits the mechanisms 'firing' - including studies from other settings may provide useful insights to refine the CPTs.

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: Applied health and care services research in mental health, realist methodology, and knowledge mobilisation.

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.

CITE

Report a concern

Author Response 07 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

07 Feb 2025

Author Response

Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which ... Continue reading Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which has helped to strengthen our study.

Our decision to limit the inclusion criteria to acute hospitals was a deliberate choice to ensure theoretical coherence and relevance to the primary focus of our study: Lean leadership in hospital-based healthcare settings. While we fully acknowledge that context extends beyond geography or physical settings, we argue that acute hospitals present a distinctive operational environment in which Lean leadership may manifest differently compared to primary care, community-based services, or voluntary, community, and social enterprise (VCSE) settings.

Acute hospitals are characterised by high patient throughput, complex multidisciplinary interactions, hierarchical decision-making structures, and regulatory and financial constraints that shape leadership behaviours and the sustainability of Lean in specific ways. Since our review seeks to understand the attributes, values, principles, and behaviours of Lean leaders in these settings, broadening the inclusion criteria to substantially different healthcare or non-healthcare settings risks introducing contextual variability that may obscure rather than refine our programme theories.

In line with realist methodology and your valuable insights, we acknowledge that learning from different settings can offer helpful perspectives. We greatly appreciate this suggestion and will ensure that where appropriate, transferable insights from other contexts are incorporated into our discussion to highlight wider implications.

Once again, we sincerely appreciate your constructive feedback and the opportunity to incorporate it into our actual realist review in response to it.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which has helped to strengthen our study.

Our decision to limit the inclusion criteria to acute hospitals was a deliberate choice to ensure theoretical coherence and relevance to the primary focus of our study: Lean leadership in hospital-based healthcare settings. While we fully acknowledge that context extends beyond geography or physical settings, we argue that acute hospitals present a distinctive operational environment in which Lean leadership may manifest differently compared to primary care, community-based services, or voluntary, community, and social enterprise (VCSE) settings.

Acute hospitals are characterised by high patient throughput, complex multidisciplinary interactions, hierarchical decision-making structures, and regulatory and financial constraints that shape leadership behaviours and the sustainability of Lean in specific ways. Since our review seeks to understand the attributes, values, principles, and behaviours of Lean leaders in these settings, broadening the inclusion criteria to substantially different healthcare or non-healthcare settings risks introducing contextual variability that may obscure rather than refine our programme theories.

In line with realist methodology and your valuable insights, we acknowledge that learning from different settings can offer helpful perspectives. We greatly appreciate this suggestion and will ensure that where appropriate, transferable insights from other contexts are incorporated into our discussion to highlight wider implications.

Once again, we sincerely appreciate your constructive feedback and the opportunity to incorporate it into our actual realist review in response to it.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 07 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

07 Feb 2025

Author Response

Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which ... Continue reading Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which has helped to strengthen our study.

Our decision to limit the inclusion criteria to acute hospitals was a deliberate choice to ensure theoretical coherence and relevance to the primary focus of our study: Lean leadership in hospital-based healthcare settings. While we fully acknowledge that context extends beyond geography or physical settings, we argue that acute hospitals present a distinctive operational environment in which Lean leadership may manifest differently compared to primary care, community-based services, or voluntary, community, and social enterprise (VCSE) settings.

Acute hospitals are characterised by high patient throughput, complex multidisciplinary interactions, hierarchical decision-making structures, and regulatory and financial constraints that shape leadership behaviours and the sustainability of Lean in specific ways. Since our review seeks to understand the attributes, values, principles, and behaviours of Lean leaders in these settings, broadening the inclusion criteria to substantially different healthcare or non-healthcare settings risks introducing contextual variability that may obscure rather than refine our programme theories.

In line with realist methodology and your valuable insights, we acknowledge that learning from different settings can offer helpful perspectives. We greatly appreciate this suggestion and will ensure that where appropriate, transferable insights from other contexts are incorporated into our discussion to highlight wider implications.

Once again, we sincerely appreciate your constructive feedback and the opportunity to incorporate it into our actual realist review in response to it.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which has helped to strengthen our study.

Our decision to limit the inclusion criteria to acute hospitals was a deliberate choice to ensure theoretical coherence and relevance to the primary focus of our study: Lean leadership in hospital-based healthcare settings. While we fully acknowledge that context extends beyond geography or physical settings, we argue that acute hospitals present a distinctive operational environment in which Lean leadership may manifest differently compared to primary care, community-based services, or voluntary, community, and social enterprise (VCSE) settings.

Acute hospitals are characterised by high patient throughput, complex multidisciplinary interactions, hierarchical decision-making structures, and regulatory and financial constraints that shape leadership behaviours and the sustainability of Lean in specific ways. Since our review seeks to understand the attributes, values, principles, and behaviours of Lean leaders in these settings, broadening the inclusion criteria to substantially different healthcare or non-healthcare settings risks introducing contextual variability that may obscure rather than refine our programme theories.

In line with realist methodology and your valuable insights, we acknowledge that learning from different settings can offer helpful perspectives. We greatly appreciate this suggestion and will ensure that where appropriate, transferable insights from other contexts are incorporated into our discussion to highlight wider implications.

Once again, we sincerely appreciate your constructive feedback and the opportunity to incorporate it into our actual realist review in response to it.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Competing Interests: No competing interests were disclosed. Close
Report a concern

Views

Reviewer Report 29 Nov 2024

Joy Furnival, Care Quality Commission, London, UK; The University of Manchester, Manchester, England, UK

Approved

https://doi.org/10.21956/hrbopenres.15288.r43326

This protocol is well structured and written and there is a clear and compelling argument for the study.

Whilst this is a good protocol, 2 areas could strengthen this further. 1) how will learning about Lean leadership from other sectors and/or healthcare, or with text books/academic chapters rather than papers/websites/grey literature be incorporated if needed 2) The inclusion criteria on Lean maturity for incorporation within the study is quite strong, given the low numbers of Lean healthcare organisations reaching this level of commitment - only 12% cited in the US study, and much may not be written into the research literature, this criteria may need further review to ensure a sufficiently meaningful sample size following the protocol.

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?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Quality improvement and regulation in healthcare

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.

CITE

Report a concern

Author Response 08 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

08 Feb 2025

Author Response

Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which ... Continue reading Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which will help enhance the study’s approach.

In response to your first point about how learning from other sectors or healthcare settings, as well as from textbooks, academic chapters, or grey literature regarding Lean leadership, will be integrated as necessary, we fully acknowledge the importance of a broad and diverse evidence base. In line with realist methodology, we recognise that knowledge of Lean leadership is not restricted to peer-reviewed journal articles, and valuable insights may be drawn from a variety of sources. While our primary focus remains on empirical studies to ensure that findings are grounded in real-world practice, we will stay open to incorporating conceptual or theoretical works that contribute meaningfully to refining our programme theories. We will ensure our search strategy accommodates the inclusion of relevant academic texts and high-quality grey literature where these sources provide essential contextual depth or explanatory insights.

With regard to the inclusion criteria on Lean maturity, we appreciate your concern regarding the relatively small number of healthcare organisations reaching this level of commitment. Our decision to focus on mature-stage Lean implementation is intended to ensure that we examine sustained Lean leadership behaviours rather than early-stage or short-lived initiatives. However, we are mindful that this could limit our sample size. We will closely monitor this issue during the search and screening process, and if necessary, we will refine our criteria to ensure a sufficiently meaningful sample while maintaining the rigour required to investigate leadership attributes, values, and principles in well-established Lean environments. Furthermore, we acknowledge that some relevant insights may exist outside traditional research literature, and we will remain attentive to integrating these perspectives where they add value to our understanding.

Once again, we are very grateful for your constructive feedback and thoughtful engagement with our study. Your comments have provided valuable considerations that will help us refine our approach further, ensuring a robust and meaningful review.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which will help enhance the study’s approach.

In response to your first point about how learning from other sectors or healthcare settings, as well as from textbooks, academic chapters, or grey literature regarding Lean leadership, will be integrated as necessary, we fully acknowledge the importance of a broad and diverse evidence base. In line with realist methodology, we recognise that knowledge of Lean leadership is not restricted to peer-reviewed journal articles, and valuable insights may be drawn from a variety of sources. While our primary focus remains on empirical studies to ensure that findings are grounded in real-world practice, we will stay open to incorporating conceptual or theoretical works that contribute meaningfully to refining our programme theories. We will ensure our search strategy accommodates the inclusion of relevant academic texts and high-quality grey literature where these sources provide essential contextual depth or explanatory insights.

With regard to the inclusion criteria on Lean maturity, we appreciate your concern regarding the relatively small number of healthcare organisations reaching this level of commitment. Our decision to focus on mature-stage Lean implementation is intended to ensure that we examine sustained Lean leadership behaviours rather than early-stage or short-lived initiatives. However, we are mindful that this could limit our sample size. We will closely monitor this issue during the search and screening process, and if necessary, we will refine our criteria to ensure a sufficiently meaningful sample while maintaining the rigour required to investigate leadership attributes, values, and principles in well-established Lean environments. Furthermore, we acknowledge that some relevant insights may exist outside traditional research literature, and we will remain attentive to integrating these perspectives where they add value to our understanding.

Once again, we are very grateful for your constructive feedback and thoughtful engagement with our study. Your comments have provided valuable considerations that will help us refine our approach further, ensuring a robust and meaningful review.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 08 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

08 Feb 2025

Author Response

Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which ... Continue reading Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which will help enhance the study’s approach.

In response to your first point about how learning from other sectors or healthcare settings, as well as from textbooks, academic chapters, or grey literature regarding Lean leadership, will be integrated as necessary, we fully acknowledge the importance of a broad and diverse evidence base. In line with realist methodology, we recognise that knowledge of Lean leadership is not restricted to peer-reviewed journal articles, and valuable insights may be drawn from a variety of sources. While our primary focus remains on empirical studies to ensure that findings are grounded in real-world practice, we will stay open to incorporating conceptual or theoretical works that contribute meaningfully to refining our programme theories. We will ensure our search strategy accommodates the inclusion of relevant academic texts and high-quality grey literature where these sources provide essential contextual depth or explanatory insights.

With regard to the inclusion criteria on Lean maturity, we appreciate your concern regarding the relatively small number of healthcare organisations reaching this level of commitment. Our decision to focus on mature-stage Lean implementation is intended to ensure that we examine sustained Lean leadership behaviours rather than early-stage or short-lived initiatives. However, we are mindful that this could limit our sample size. We will closely monitor this issue during the search and screening process, and if necessary, we will refine our criteria to ensure a sufficiently meaningful sample while maintaining the rigour required to investigate leadership attributes, values, and principles in well-established Lean environments. Furthermore, we acknowledge that some relevant insights may exist outside traditional research literature, and we will remain attentive to integrating these perspectives where they add value to our understanding.

Once again, we are very grateful for your constructive feedback and thoughtful engagement with our study. Your comments have provided valuable considerations that will help us refine our approach further, ensuring a robust and meaningful review.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which will help enhance the study’s approach.

In response to your first point about how learning from other sectors or healthcare settings, as well as from textbooks, academic chapters, or grey literature regarding Lean leadership, will be integrated as necessary, we fully acknowledge the importance of a broad and diverse evidence base. In line with realist methodology, we recognise that knowledge of Lean leadership is not restricted to peer-reviewed journal articles, and valuable insights may be drawn from a variety of sources. While our primary focus remains on empirical studies to ensure that findings are grounded in real-world practice, we will stay open to incorporating conceptual or theoretical works that contribute meaningfully to refining our programme theories. We will ensure our search strategy accommodates the inclusion of relevant academic texts and high-quality grey literature where these sources provide essential contextual depth or explanatory insights.

With regard to the inclusion criteria on Lean maturity, we appreciate your concern regarding the relatively small number of healthcare organisations reaching this level of commitment. Our decision to focus on mature-stage Lean implementation is intended to ensure that we examine sustained Lean leadership behaviours rather than early-stage or short-lived initiatives. However, we are mindful that this could limit our sample size. We will closely monitor this issue during the search and screening process, and if necessary, we will refine our criteria to ensure a sufficiently meaningful sample while maintaining the rigour required to investigate leadership attributes, values, and principles in well-established Lean environments. Furthermore, we acknowledge that some relevant insights may exist outside traditional research literature, and we will remain attentive to integrating these perspectives where they add value to our understanding.

Once again, we are very grateful for your constructive feedback and thoughtful engagement with our study. Your comments have provided valuable considerations that will help us refine our approach further, ensuring a robust and meaningful review.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara
Competing Interests: No competing interests were disclosed. Close
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VERSION 1 PUBLISHED 13 Aug 2024

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Reviewer Reports

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Version 1 13 Aug 24	read	read

Joy Furnival, Care Quality Commission, London, UK; The University of Manchester, Manchester, UK
Rebecca Hardwick, University of Plymouth, Plymouth, UK

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Reviewer Report

14 Views

31 Jan 2025 | for Version 1

Rebecca Hardwick, University of Plymouth, Plymouth, UK

14 Views Cite this report Responses(1)

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

Applied health and care services research in mental health, realist methodology, and knowledge mobilisation.

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.

Respond to this report

Responses (1)

Author Response

07 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

Dear Dr Hardwick

Thank you for your thoughtful and constructive review and for approving this protocol. We greatly appreciate your engagement with our work and your insightful feedback, which has helped to strengthen our study.

Our decision to limit the inclusion criteria to acute hospitals was a deliberate choice to ensure theoretical coherence and relevance to the primary focus of our study: Lean leadership in hospital-based healthcare settings. While we fully acknowledge that context extends beyond geography or physical settings, we argue that acute hospitals present a distinctive operational environment in which Lean leadership may manifest differently compared to primary care, community-based services, or voluntary, community, and social enterprise (VCSE) settings.

Acute hospitals are characterised by high patient throughput, complex multidisciplinary interactions, hierarchical decision-making structures, and regulatory and financial constraints that shape leadership behaviours and the sustainability of Lean in specific ways. Since our review seeks to understand the attributes, values, principles, and behaviours of Lean leaders in these settings, broadening the inclusion criteria to substantially different healthcare or non-healthcare settings risks introducing contextual variability that may obscure rather than refine our programme theories.

In line with realist methodology and your valuable insights, we acknowledge that learning from different settings can offer helpful perspectives. We greatly appreciate this suggestion and will ensure that where appropriate, transferable insights from other contexts are incorporated into our discussion to highlight wider implications.

Once again, we sincerely appreciate your constructive feedback and the opportunity to incorporate it into our actual realist review in response to it.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara

View more View less

Competing Interests

No competing interests were disclosed.

Back to all reports

Reviewer Report

27 Views

29 Nov 2024 | for Version 1

Joy Furnival, Care Quality Commission, London, UK; The University of Manchester, Manchester, England, UK

27 Views Cite this report Responses(1)

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?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Quality improvement and regulation in healthcare

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.

Respond to this report

Responses (1)

Author Response

08 Feb 2025

Sean Paul Teeling, UCD Centre for Interdisciplinary Research, Education and Innovation in Health Systems, School of Nursing, Midwifery & Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland

Dear Dr Furnival

Thank you for your detailed and insightful review and for approving this protocol. We truly appreciate your engagement with our work and your valuable comments, which will help enhance the study’s approach.

In response to your first point about how learning from other sectors or healthcare settings, as well as from textbooks, academic chapters, or grey literature regarding Lean leadership, will be integrated as necessary, we fully acknowledge the importance of a broad and diverse evidence base. In line with realist methodology, we recognise that knowledge of Lean leadership is not restricted to peer-reviewed journal articles, and valuable insights may be drawn from a variety of sources. While our primary focus remains on empirical studies to ensure that findings are grounded in real-world practice, we will stay open to incorporating conceptual or theoretical works that contribute meaningfully to refining our programme theories. We will ensure our search strategy accommodates the inclusion of relevant academic texts and high-quality grey literature where these sources provide essential contextual depth or explanatory insights.

With regard to the inclusion criteria on Lean maturity, we appreciate your concern regarding the relatively small number of healthcare organisations reaching this level of commitment. Our decision to focus on mature-stage Lean implementation is intended to ensure that we examine sustained Lean leadership behaviours rather than early-stage or short-lived initiatives. However, we are mindful that this could limit our sample size. We will closely monitor this issue during the search and screening process, and if necessary, we will refine our criteria to ensure a sufficiently meaningful sample while maintaining the rigour required to investigate leadership attributes, values, and principles in well-established Lean environments. Furthermore, we acknowledge that some relevant insights may exist outside traditional research literature, and we will remain attentive to integrating these perspectives where they add value to our understanding.

Once again, we are very grateful for your constructive feedback and thoughtful engagement with our study. Your comments have provided valuable considerations that will help us refine our approach further, ensuring a robust and meaningful review.

Anne Marie Keown
Dr Seán Paul Teeling
Prof Martin McNamara

View more View less

Competing Interests

No competing interests were disclosed.

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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The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol

Abstract

Background

Methods

Conclusion

Keywords

Introduction

Continuous improvement

Lean in healthcare

Lean leadership

Use of realist inquiry

Protocol

Methods

Table 1. PICOC used to clarify inclusion and exclusion criteria.

Ethics

Conclusion

Systematic review registration

Ethics

Consent to participate

Data availability

Underlying data

Extended data

Acknowledgments

References

Comments on this article Comments (0)

Open Peer Review

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Open Peer Review

Reviewer Status

Reviewer Reports

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Are you a HRB-funded researcher?

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The contribution of leaders' and managers' attributes, values, principles, and behaviours to the sustainable implementation of Lean in healthcare: A realist review protocol

Abstract

Background

Methods

Conclusion

Keywords

Introduction

Continuous improvement

Lean in healthcare

Lean leadership

Use of realist inquiry

Protocol

Methods

Table 1. PICOC used to clarify inclusion and exclusion criteria.

Ethics

Conclusion

Systematic review registration

Ethics

Consent to participate

Data availability

Underlying data

Extended data

Acknowledgments

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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Are you a HRB-funded researcher?

Thank you!