Towards an operational definition of Lean in healthcare ... · Although Lean has been widely...

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Towards an operational definition of Lean in healthcare. What can we learn from the literature?

Thomas Rotter1* Email: [email protected]

Christopher Plishka1 Email: [email protected]

Adegboyega Lawal1

Email: [email protected]

Liz Harrison2 Email: [email protected]

Nazmi Sari3 Email: [email protected]

Donna Goodridge4 Email: [email protected]

Rachel Flynn5


James Chan6


Michelle Fiander7


Bonnie Poksinska8 Email: [email protected]

Keith Willoughby9 Email: [email protected]

Leigh Kinsman10 Email: [email protected]

mailto:[email protected]











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1College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada

2 School of Physical Therapy, College of Medicine, University of Saskatchewan, Saskatoon, Canada

3 Department of Economics, University of Saskatchewan, Saskatoon, Canada

4 College of Medicine, University of Saskatchewan, Saskatoon, Canada

5Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada

6 School of Health Sciences, University of Northern British Columbia, Canada

7 Fiander Consulting: Systematic Reviewing and Literature Searching, Winnipeg, MB

8 Department of Management and Engineering, Lingkoeping University, Sweden

9Edwards School of Business, University of Saskatchewan, Saskatoon, Canada

10University of Tasmania and Tasmanian Health Organisation (North), Launceston, Tasmania, Australia

*Corresponding author. College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Canada

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Abstract Background Due to widespread lack of agreement as to what constitutes Lean management in healthcare (Lean), this paper outlines the process utilized to develop, test and apply an operational definition of Lean in Healthcare settings. The resulting working definition will be key to conducting a high quality systematic review on the effectiveness of Lean in healthcare. Methods Literature search: A search strategy for OVID Medline was developed and applied from database inception date to December 2013. Criteria development: Approaches suggested by Kinsman at al. and Wieland at al. were followed to develop a working definition of Lean healthcare management, irrespective of the terminology used. The four stages were: 1) extract data regarding Lean methods and themes, 2) create an operational definition based on these methods and themes, 3) pilot test these criteria, and 4) re-screen search results based on the criteria. Results Based on the methods reported in the primary studies, defining characteristics of Lean healthcare management were identified: Lean philosophies, Lean assessment activities, and Lean improvement activities. As a result we developed minimum content criteria to include only relevant Lean investigations in our systematic review. In order to meet our inclusion criteria, an organization or subunit of an organization (e.g. department or ward) should have 1) demonstrated a continuing commitment to Lean philosophies, and 2) utilized at least one Lean assessment activity or Lean improvement activity. A data extraction form based on these inclusion criteria was subsequently developed. Conclusions Although an operational definition on Lean healthcare management proved very helpful in developing objective screening criteria, a number of shortcomings are discussed. The working definition is considered a first step in solidifying the definition and quality of reporting regarding Lean in healthcare.

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Background Healthcare systems are under pressure to improve patient outcomes while simultaneously achieving greater efficiencies [1]. Industrial improvement approaches, such as the Lean Management System (Lean), which originates from the Toyota Production System, are increasingly being adopted by healthcare organizations to enhance quality, capacity and safety while containing costs [2]. Lean production is described as “an integrated socio-technical system whose main objective is to eliminate waste by concurrently reducing or minimizing supplier, customer, and internal variability” [3]. It aims to develop a company culture based on continuous improvement and respect for people to reduce costs and improve customer value[4]. To achieve these goals a number of common Lean activities are used. These activities are depicted in table 1. PLEASE ADD TABLE 1 HERE The activities described in Table 1 are used in different ways and adopted to varying extents. In addition there is widespread lack of agreement regarding what constitutes Lean healthcare management. This paper aims to describe the process of developing an operational definition of Lean healthcare management, based on the approaches suggested by Kinsman at al. [5] and Wieland at al. [6].

Lean Implementation in Saskatchewan Although Lean has been widely applied in healthcare systems within Canada, the United States, the United Kingdom and Australia [1, 2, 7-10], the Government of Saskatchewan is the first Canadian jurisdiction to commit to province-wide implementation of Lean [7]. This has created an unprecedented opportunity to rigorously investigate the impact of Lean and its capacity to facilitate access to cost-effective, high quality healthcare in a timely manner [11]. The Saskatchewan Health Quality Council (HQC) commissioned a first phase, 12-month (March 2013-March 2014) baseline study that developed research methods and gathered data for a multi-year evaluation of the implementation of Lean throughout Saskatchewan’s healthcare system [11, 12]. This included a scoping review of Lean management in healthcare.

Problem definition and purpose of this paper The results of the scoping review revealed that despite increased use of Lean terminology and popularization of Lean management approaches, especially in the hospital sector, there is little agreement regarding how Lean is described and defined in the literature [12]. Primary studies investigating Lean implementation often lack relevant definitions [13] and vaguely refer to Lean management, Lean principles or Lean thinking [14-17]. The notion of poorly defined quality improvement interventions is not new. A systematic review by Kaplan et al. [18], which focused on the influence of context on quality improvement success, highlights a lack of adequate definitions in the literature in the area of quality improvement [18]. As a follow-up project to the scoping review, our team is conducting a systematic review on the effectiveness of Lean management in healthcare [12]. Given the lack of an internationally agreed definition of Lean healthcare management, a critical first step was to develop an operational

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definition to ensure that the systematic review includes only those studies reflecting the core principles of Lean management, irrespective of the terminology used.

This paper describes the process and outcomes related to creating an evidence-informed operational definition of Lean healthcare management. This was done by utilizing the approaches suggested by Kinsman at al. [5] and Wieland at al. [6]. As opposed to a theoretical definition, which describes the basic principles of an intervention, an operational definition tests whether a specific component is needed to clearly describe an intervention and to distinguish it from similar interventions [6]. This can be achieved through an iterative process of testing, updating and retesting the criteria to identify the characteristics of interest [5, 6].

Methods Operational definition Kinsman et al. describe four steps to develop evidence-informed operational criteria to define clinical pathways, a process relevant to other complex interventions such as Lean management: 1) identify relevant publications on theoretical definitions, 2) synthesize similar components and develop draft criteria, 3) test the criteria, and 4) modify and retest the criteria [5]. Wieland and colleagues propose two major steps to develop an operational definition of complementary and alternative medicine for the Cochrane Collaboration: 1) develop an operational definition by using relevant and available theoretical definitions [6], and 2) test the application of the working definition to identify relevant studies [6]. Both approaches use similar methods to achieve the same goal, differing only in the way steps are described and categorized. We utilized the work of both authors to develop an operational definition of Lean management in health care (see criteria development).

Literature search We developed a search strategy [Appendix 1] for OVID Medline and searched from database inception date to December 2013, with neither language nor date limits. Hand searching was also used to identify additional records. Duplicates were removed using reference management software.

Screening methods Titles, abstracts and full text articles of search results were screened independently by two authors. Disagreements were resolved by discussion or by a third author. References were included or excluded using the definition and inclusion criteria published in our systematic review protocol [12]. The population, intervention, comparison and outcomes (PICO) used as inclusion/exclusion criteria in the protocol are presented in Table 2. After title and abstract screening was completed the full text of the remaining primary articles was retrieved.

Criteria development As mentioned, the four stages used to develop and test an evidence-based working definition of Lean management were: 1) extract data regarding Lean methods and themes, 2) create an operational definition based on these methods and themes, 3) pilot test criteria, and 4) re-screen search results based on the criteria.

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In the first stage, Lean activities reported in each of the primary articles meeting the inclusion criteria were recorded. In the second stage results of data extraction were synthesized to create an operational definition. The third stage was an iterative process of testing, updating and retesting the criteria for the working definition. At this stage the operational definition was applied to all primary articles to assess coherence between the criteria developed and the methods reported in the primary articles. Following this application, the definition was updated to address any shortcomings that became apparent. In the fourth stage, the operational definition was re-applied to all search hits identified with the search strategy (titles, abstracts and full text articles) to determine the extent to which screening results changed due to the newly developed operational definition on Lean management in healthcare. Data was also extracted in order to portray the maturity of the Lean management systems described in the included primary articles. These variables were: duration of an organization’s commitment to Lean and duration of the follow-up period reported.

The duration of an organization’s commitment to Lean, measured in years, was calculated as the time from which an organization-wide commitment to Lean was made to the year the article was published. The duration of the follow-up period was measured in months. This variable represented the length of time during which results of a Lean intervention were monitored. It was calculated as the period between the conclusion of the specific Lean intervention described in the article and the latest date on which an outcome was measured. Articles frequently failed to report specific dates but instead reported only the month in which an intervention occurred or the month in which an outcome was measured. In these cases it was assumed that interventions finished on the first day of the month and outcomes were observed on the final day of the month.

PLEASE ADD TABLE 2 HERE

Results Literature screening The OVID Medline search identified 511 records, with two additional records identified via hand searching. Nine duplicates were identified, leaving 503 records. During the title and abstract screening phase, 371 records were excluded as they did not meet the inclusion criteria. The full text of the remaining 132 references was examined and 33 studies were selected for inclusion [15, 17, 19-49]. The flow chart for this process, including the reasons for exclusion during full text screening, is presented in Figure 1. PLEASE ADD FIGURE 1 HERE Data extraction and synthesis The Lean methods used in each of the 33 primary articles were recorded. Results of this process showed that 27 articles [15, 17, 19, 21-26, 28, 29, 31, 33-45, 47, 49] reported a dedication to Lean philosophies throughout the organization or a subunit of the organization, 26 studies [17, 20, 23-

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36, 38-40, 42-47, 49] described the use of Value Stream Mapping (VSM), 15 studies [15, 17, 19, 21, 22, 24, 34, 35, 39-42, 44, 47, 48] illustrated the use of a Rapid Process Improvement Workshop (RPIW), seven studies [17, 23, 31, 39, 41, 45, 47] utilized 5S methodologies, six [17, 24, 31, 41, 44, 48] reported the use of Gemba walks, four [19, 23, 40, 48] depicted Standard Work, three [19, 21, 44] reported A3 Problem Solving, three [37, 45, 46] utilized Levelled production, three [24, 41, 45] illustrated the use of Daily Visual Management (DVM) and two [22, 24] applied Stop the Line techniques [21, 23]. A description of the methods and Lean activities used in each study can be found in Table 3. PLEASE ADD TABLE 3 HERE Operational definition

Based on the Lean methods recorded, and inspired by the categorizations of Radnor et al. [50] (assessment activities, improvement activities, performance monitoring) and Poksinska et al. [51] (focus on patients, learning to see process shortcomings, specifying how work should be done), three defining characteristics of Lean were identified: Lean philosophies, Lean assessment activities and Lean improvement activities.

Lean philosophies refer to an overarching set of principles aimed at transforming workplace culture [52]. These philosophies include a dedication to continuous improvement [53-55] and a focus on: eliminating waste [51, 53, 55]; improving the flow of patients, providers and supplies [51, 54, 56]; and ensuring all processes add value to customers [57]. Further, Lean philosophies suggest that problems are identified and addressed by front line staff members as it is believed that the people doing the work are best suited to create solutions [52, 54, 58].

Lean assessment activities work as analytic tools to identify waste and areas of possible improvement. These activities allow team members to see problems and identify opportunities to reduce waste and make improvements, but do not prescribe specific solutions. Lean assessment activities include VSM; spaghetti diagrams; RPIWs; Gemba walks; and root cause analysis.

Lean improvement activities suggest specific ways to reduce waste and improve the workplace and set up new working practices[51]. These include actions and concepts such as: 5S events; Levelled production; DVM (including Kanban supply management); Standard Work; and Stop the Line techniques.

Based on these components the review team created an inclusion criterion which required that all included studies focus on interventions which: 1) occurred in an organization or subunit of an organization (e.g., department or ward) which has made a continuing commitment to Lean philosophies; and 2) utilized at least one Lean assessment activity or Lean improvement activity. A data extraction form based on these inclusion criteria can be found in Appendix 2.

Application of criteria

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In order to test the coherence between the primary studies and the operational definition, the definition was applied to each of the studies. Results indicated that 27 [15, 17, 19, 21-26, 28, 29, 31, 33-45, 47] of the 33 [4, 13, 20-50] studies fit well with the criteria and would be included based on this definition. The remaining 6 studies [20, 27, 30, 32, 46, 49] would have been excluded due to their failure to demonstrate dedication to Lean philosophies. Additional information regarding excluded studies can be found in Appendix 3. Of the 27 included studies, 15 [15, 21, 25, 26, 28, 29, 33-36, 38, 39, 42-44] reported only a Lean assessment activity, 11 [17, 19, 22-24, 31, 40, 41, 45, 47, 48] reported both assessment and improvement activities, and 1 study [37] reported using only a Lean improvement activity.

Study selection after applying operational definition (Re-screening)

All search results were re-screened based on the operational definition presented above. During the title and abstract screening phase, 367 records not meeting the inclusion criteria were excluded. Full text assessment of the remaining 136 records resulted in selecting 43 studies [15, 17, 19, 21-26, 28, 29, 31, 33-45, 47, 48, 50, 59-73]. This process excluded 6 previously included studies [20, 27, 30, 32, 46, 49] and included 16 previously excluded studies [50, 59-73]. The flow chart for this process, including reasons for exclusion during full text screening, is presented in Figure 2. A comparison between the studies selected during the initial screening and later re-screening phase can be found in Table 4.

PLEASE ADD FIGURE 2 HERE


Maturity of Lean management within organizations

Of the 43 articles selected during the re-screening phase, 5 reported on organizations which had adopted Lean for less than five years, 9 reported on organizations which had adopted Lean for five to nine years, none reported on organizations which had adopted Lean for more than ten years and 29 failed to provide information on the duration of Lean adoption within the organization. Within this group, 11 studies reported a follow-up of six months or less, 18 reported a follow-up of seven to 24 months, 5 reported a follow-up of more than two years and 9 failed to provide adequate information to determine length of follow-up. For additional details see Table 5.


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Discussion and Limitations

Although the operational definition proved useful in creating more objective screening criteria, a number of shortcomings became apparent through application. First, the articles on which the definition is based appear to describe Lean implementation rather than Lean management systems in healthcare. Second, it is often difficult to distinguish assessment from improvement activities. Third, limitations also arise as the result of developing an operational definition rather than performing a scientific concept analysis as described by Walker and Avant [74].

Definition of Lean implementation vs. definition of Lean management system

There is a possibility that the definition generated may not be representative of a mature or stable Lean management system, but instead reflects the implementation process of Lean management. The majority of the 33 studies upon which the definition was based described Lean management in organizations in early stages of Lean implementation. Evidence for this can be found when analyzing the 33 articles upon which the definition is based. None of these studies provide evidence to suggest they describe an organization utilizing Lean management for more than ten years. The 43 studies identified through the re-screening process showed similar outcomes, as no articles show evidence of organizations which have utilized Lean management for more than ten years and only 5 providing a follow-up of more than two years.

Additional evidence suggesting the definition is implementation-focused is seen in the finding that the most commonly used Lean assessment tool is VSM. Although VSM is commonly used in Lean interventions, it is incorrect to assume that mapping value streams alone constitute the Lean management system in healthcare. The use of VSM is rather a consequence of following a common improvement cycle such as PDSA (Plan, Do, Study, Act). When implementing such an approach, one must understand the problems, plan and implement solutions before the new working practices are set and followed-up upon.

It is also important to realize that the definition was developed based on empirical cases, rather than theoretical or conceptual articles. As a result, the studies captured are likely to be focused on the process of implementing Lean interventions rather than providing a conceptual framework for Lean. Taken together, our reliance on case studies describing organizations in the early stages of Lean implementation results in the possibility that the definition developed in this paper provides a strong description of the Lean implementation process but fails to encompass later stages of Lean management. Future research, including the planned concept analysis, will need to have an increased focused on the operation and sustainability phases of Lean management.

Categorization of assessment and improvement activities

The issue of an imperfect distinction between assessment and improvement activities results from the fact that characterizations were made based on the primary nature of each activity. However, many Lean activities include both assessment and improvement components. This can be seen in 5S events where the ‘sort’ component requires team members to identify and eliminate unneeded

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tools, parts or supplies and therefore acts as an assessment activity. In contrast, the ‘set in order’ and ‘standardize’ components dictate that items should have a standardized location and that these locations should be visually represented; therefore these components act as a Lean improvement activity.

Operational definition vs. concept analysis

It is important to understand that we created an operational definition rather than performing a scientific concept analysis. The team followed the methodological approach proposed by Kinsman at al. [5] and Wieland at al. [6] to develop a working definition on Lean management in healthcare by operationalizing evidence-informed criteria to clearly describe and distinguish the Lean concept from similar approaches (e.g., Six Sigma). The team did not aim to conduct a systematic concept analysis as described by Walker and Avant [74]. The Walker and Avant approach aims to inform theory development and is a systematic process consisting of eight comprehensive steps (concept selection, aims, uses of concept, defining attributes, development of a model case, additional cases, antecedents & consequences, and definition of empirical referents) [74]. This approach is considered the gold standard in concept and theory development. However, conducting a systematic concept analysis to develop a program theory is a comprehensive, multi-year process and requires substantial resources and expertise. This may not be feasible for researchers or healthcare decision-makers. As a result, developing ‘minimum inclusion criteria’ for systematic reviews of complex interventions is a preliminary step to ensuring all important studies are included while simultaneously including only relevant evidence.

Importance of an operational definition

Our effort to develop an operational definition of Lean management in healthcare clearly illustrates the importance of having a clear operational definition for systematic reviews on complex interventions. Without the application of the Lean content criteria, 16 relevant studies would have been missed, and 6 others would have been included that did not meet the definition of Lean management. This resulted in a net increase of 10 studies (23% of included studies). It’s interesting that applying the operational definition resulted in a substantially higher number of Lean investigations included (43 studies) as compared to 33 studies included using the definition and inclusion criteria published in the systematic review protocol [12]. The lack of adequate definitions for complex interventions such as Lean management is evident and we recommend the approach suggested by Kinsman at al. [5] and Wieland at al. [6]: to develop content criteria for Cochrane systematic reviews. The process of developing content criteria on Lean in healthcare strongly supports the finding from Kaplan et al. that many quality improvement projects use weak definitions.

These weak definitions became especially obvious throughout the process of categorizing Lean activities into assessment and improvement activities. During this categorization process, it became apparent that some of the concepts mentioned in the literature were not actually activities, but were goals or outcomes (e.g., just-in-time production and waste elimination). We refer to these as intermediate outcomes of Lean as they are steps toward the goals of increased value, improved flow and increased efficiency.

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The weak definitions relating to Lean were also obvious in the way Lean methods were reported in the literature. One major shortcoming identified was that many authors clearly did not have a standard template regarding which components of the Lean intervention to describe. This was most obvious in reporting regarding Lean philosophies as it was unclear whether some organizations made a commitment to these philosophies or whether the intervention was a single ‘Lean inspired’ experiment. This was the reason for excluding 6 of the originally included studies. This is a necessary distinction as Lean is an overall management system rather than a set of tools [75]. Many tools, such as VSM, spaghetti diagrams and root cause analysis are not unique to Lean and are used in other continuous quality improvement (CQI) practices. As such, it is hoped this operational definition of Lean implementation will help improve reporting of Lean interventions used in healthcare.

Conclusion

This paper outlines the process utilized to develop, test and apply an operational definition of Lean management in healthcare. This process proved extremely beneficial as it helped to ensure the screening process captured all relevant studies while simultaneously eliminating irrelevant studies, thus demonstrating the importance of a well-defined operational definition in ensuring an unbiased systematic review. However, the definition developed through the process seems to be a definition of Lean implementation rather than a definition of Lean management in healthcare. To develop an accurate operational definition it is necessary to capture studies which describe mature Lean management practices in healthcare. Unfortunately, the literature in this respect is limited. It is hoped that the operational definition of Lean implementation developed in this paper will act as a first step in solidifying the definition, conceptualization and quality of reporting regarding Lean in healthcare.

Competing interests The authors declare they have no competing interest.

Ethical approval: The University of Saskatchewan Behavioural Research Ethics Board has reviewed and approved the proposal for the Lean baseline study including the systematic review on Lean healthcare management. Certificate of Approval: Beh # 13-294 (Expiry date: 17-Sep-2016)

Authors’ contributions All authors were involved in the development of the study design. TR led the project and coordinated the collection of data with CP. TR, CP and LK conducted the analysis and all authors were involved in the interpretation of data, making conclusions and in the first draft of the manuscript. Our Lean experts BP and KW provided a critical appraisal of our working definition of Lean management. All authors read and approved the final manuscript.

Acknowledgements This research project and manuscript development has been supported by the Saskatchewan Health Quality Council (HQC, contract C7036) and with an internal grant from the College of Pharmacy and Nutrition at the University of Saskatchewan, Canada. We acknowledge the financial support provided for this project, and the critical appraisal and help provided by Dr. Gary Teare,

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HQC’s CEO. We also wish to acknowledge the contributions of participants, who took time from their very busy schedules to share their perspectives on the relevance of literature findings for the development of our working definition.

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49. Yousri TA, Khan Z, Chakrabarti D, Fernandes R, Wahab K: Lean thinking: can it improve the outcome of fracture neck of femur patients in a district general hospital? Injury 2011, 42(11):1234-1237.

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50. Radnor ZJ, Holweg M, Waring J: Lean in healthcare: The unfilled promise? Soc Sci Med 2012, 74(3):364-371.

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59. Aasebo U, Strom HH, Postmyr M: The Lean method as a clinical pathway facilitator in patients with lung cancer. The clinical respiratory journal 2012, 6(3):169-174.

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69. Serrano L, Hegge P, Sato B, Richmond B, Stahnke L: Using LEAN principles to improve quality, patient safety, and workflow in histology and anatomic pathology. Advances in Anatomic Pathology 2010, 17(3):215-221.

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71. Tsasis P, Bruce-Barrett C: Organizational change through Lean Thinking. Health Services Management Research 2008, 21(3):192-198.

72. Vats A, Goin KH, Fortenberry JD: Lean analysis of a pediatric intensive care unit physician group rounding process to identify inefficiencies and opportunities for improvement. Pediatric Critical Care Medicine 2011, 12(4):415-421.

73. Wong R, Levi AW, Harigopal M, Schofield K, Chhieng DC: The positive impact of simultaneous implementation of the BD FocalPoint GS Imaging System and lean principles on the operation of gynecologic cytology. Archives of Pathology & Laboratory Medicine 2012, 136(2):183-189.

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Glossary.pdf]

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Tables: Table 1: Lean activities used

Lean activity Description

Value Stream Mapping

A Value Stream Map in healthcare is a visual tool plotting all processes required to deliver a healthcare service. It facilitates enhanced understanding of the flow of patients, supplies or information through a healthcare process [76].

RPIW

RPIW stands for Rapid Process Improvement Workshop. An RPIW is generally a week-long event where teams of patients and their families, staff and clinicians focus on one problem, identify the root cause, create solutions and implement sustainable changes[77].

5S events 5S stands for ‘Sort, Sweep, Simplify, Standardize, Sustain/Self-Discipline’, and represents a set of concepts that ensure a clean and well organized work place[76].

A3 Problem Solving

A3 Problem Solving refers to a standardized method of addressing problems utilizing an A3 report, which is a standardized form of planning and report writing. The content follows the Plan-Do-Study-Act (PDSA) cycle [78].

Gemba walk

Gemba is a Japanese term which means ‘the work place’. It simply refers to the ‘work floor’ or unit where the necessary patient care is provided [77]. A Gemba walk refers to the act of a manager or CEO spending time on the hospital floor and speaking to front-line staff who understand the organization’s problems and shortcomings [56].

Stop the Line techniques

Stop the Line techniques come from manufacturing (specifically the assembly line) and here refer to the act of enabling all healthcare professionals to immediately stop the line (a process of care) when a defect or error is realized. This prevents errors from being passed on and makes the cause of errors more salient [79].

Levelled production

Levelled production in healthcare refers to the elimination of unnecessary variation (unevenness) to avoid bottlenecks and backups which can lead to patient wait times and wasted time for healthcare professionals [56]. Levelled production requires a rigorous study of organizational processes, and scheduling patients and clients according to actual or forecasted demand [56].

DVM

DVM (Daily Visual Management) is a system aimed at improving communication and ensuring information is available when needed. This is done by displaying objectives, metrics and progress transparently and using measures (e.g., staff injuries, patient falls) to manage change [76]. DVM is closely linked to the wider strategic management system or policy deployment system of an organization [56].

Standard Work

Standard Work in healthcare details the steps in a course of treatment or care in a multi-disciplinary care plan. It prescribes a uniform way to achieve a desired service or patient outcome based on the best available evidence. Standard Work serves as the basis for any kind of work improvement [76].

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Table 2: PICO used in the review protocol

PICO In Ex

Population All healthcare systems, including hospital care, primary care, community or home care and rehabilitation

Animal studies Other industries Editorials

Intervention

Lean methodologies

Simulation studies Impact of Lean on teaching

Lean implementation activities • RPIW • Lean basics workshop • Other concepts used within Lean

Comparison Pre Lean process

Outcome

Comparison of the outcomes pre and post Lean with respect to patients, healthcare professions, decision-makers and the healthcare system

Teaching

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Table 3: Lean methods used in each of the 33 primary articles

Lean

Philosophy

Lean Assessment Activities Lean Improvement Activities

Study ID A3 Gemba

Walk RPIW VSM 5S Stop the

Line Techniques

Levelled Production DVM Standard

Work

Atkinson 2012 [15] x x Barnas 2011 [19] x x x x Beard 2010 [20] x Biffl 2011 [21] x x x Blackmore 2013 [22] x x x Cankovic 2009 [23] x x x x Chiodo 2012 [24] x x x x x x Cima 2011 [25] x x Collar 2012 [26] x x Fischman 2010 [27] x Ford 2012 [28] x x Grove 2010 [29] x x Harmelink 2008 [30] x Hummer 2009 [31] x x x x Kelly 2007 [32] x King 2006 [33] x x McDermott 2013 [34] x x x Melanson 2009 [35] x x x Michael 2013 [36] x x Morrison 2011 [37] x x Murrel 2011 [38] x x Naik 2012 [39] x x x x Ng 2010 [40] x x x x O'Neil 2011 [41] x x x x x Piggott 2011 [42] x x x Smith 2011 [43] x x Smith 2012 [17] x x x x x Smith 2012a [44] x x x x x Ulhassan 2013 [45] x x x x x Van Lent 2009 [46] x x Waldhausen 2011 [47] x x x x Yerian 2012 [48] x x x x Yousri 2011 [49] x Total 27 3 6 15 26 7 2 3 3 4

Legend: A3 = A3 Problem Solving, RPIW = Rapid Process Improvement Workshop, VSM = Value Stream Mapping, 5S = Sort, Sweep, Simplify, Standardize, Sustain/Self-Discipline, DVM = Daily Visual Management

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Table 4: Comparison of screening results before and after the development of the operational definition on Lean.

Study ID Original Screening Updated Screening Change in Inclusion Status

Aasebo 2012 [59] x + Atkinson 2012 [15] x x 0 Barnas 2011 [19] x x 0 Beard 2010 [20] x - Biffl 2011 [21] x x 0 Blackmore 2013 [22] x x 0 Cankovic 2009 [23] x x 0 Chiodo 2012 [24] x x 0 Cima 2011 [25] x x 0 Collar 2012 [26] x x 0 Dickson 2009a [61] x + Dickson 2009a [60] x + Fischman 2010 [27] x - Ford 2012 [28] x x 0 Grove 2010 [29] x x 0 Hintzen 2009 [62] x + Harmelink 2008 [30] x - Hummer 2009 [31] x x 0 Kelly 2007 [32] x - Karstoft 2011 [63] x + Kim 2007 [64] x + Kimsey 2010 [65] x + King 2006 [33] x x 0 Leslie 2006 [66] x + McDermott 2013 [34] x x 0 Melanson 2009 [35] x x 0 Michael 2013 [36] x x 0 Morrison 2011 [37] x x 0 Murrel 2011 [38] x x 0 Naik 2012 [39] x x 0 Ng 2010 [40] x x 0 O'Neil 2011 [41] x x 0 Persoon 2006 [67] x + Piggott 2011 [42] x x 0 Raab 2008 [68] x + Radnor 2012 [50] x + Serrano 2010 [69] x + Smith 2009 [70] x + Smith 2011 [43] x x 0

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Smith 2012 [17] x x 0 Smith 2012a [44] x x 0 Tsasis 2008 [71] x + Ulhassan 2013 [45] x x 0 Van Lent 2009 [46] x - Vats 2011 [72] x + Waldhausen 2011 [47] x x 0 Yerian 2012 [48] x x 0 Yousri 2011 [49] x - Wong 2012 [73] x +

Total 33 44

Legend: + = Added, 0 = Unchanged, - = Removed

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Table 5: Measures of Lean management maturity

Duration of Lean Adoption

Original Screening

Period Number of Articles Reference

Less than five years 2 [39, 42]

Five to nine years 6 [15, 19, 21, 28, 40, 41]

Greater than ten years 0

N/A 25 [17, 20, 22-27, 29-38, 43-49]

Re-screening Period Number of Articles Reference

Less than five years 5 [39, 42, 60, 65, 70]

Five to nine years 9 [15, 19, 21, 28, 40, 41, 63, 68]

Greater than ten years 0

N/A 29 [17, 22-26, 29, 31, 33-38, 43-45, 47, 48, 50, 59, 60, 62, 64, 66, 67, 71-73]

Duration of Follow-up Period

Original Screening

Period Number of Articles Reference

Less than six months 9 [15, 26, 27, 34, 36, 37, 41-43]

Seven to 24 months 18 [17, 20, 22-25, 28, 29, 31-33, 35, 38-40, 44, 47, 49]

Greater than 24 months

4 [19, 21, 45, 46]

N/A 2 [30, 48]

Re-screening Period Number of Articles Reference

Less than six months 11 [15, 26, 34, 36, 37, 41-43, 50, 59, 61]

Seven to 24 months 18 [17, 22-25, 28, 29, 31, 33, 35, 38-40, 44, 47, 62, 67, 70]

Greater than 24 months

5 [19, 21, 45, 60, 68]

N/A 9 [48, 63-66, 69, 71-73]

Legend: N/A = not reported, not available

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Figure 1: Flow chart for screening with original inclusion criteria

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Figure 2: flow chart for updated screening using the operational definition on Lean.

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Appendix 1: Search strategy: OVID Medline (R) In-Process & Other Non-Indexed Citations and OVID Medline (R) <1946 -> Search date: December 2013 1 (lean and (approach or business model? or care or collaborat$ or design$ or enterpri?e or healthcare or health care or implementation? or industry or initiative? or intervention$ or leader$ or management or methodolog$ or method? or oncology or organi?ation$ or plan or planning or philosophy or practice or practices or principles or principle or process improvement? or production or program? or programme or programmes or quality or redesign$ or reengineer$ or restructur$ or reorgani$ or safety or sigma or strategy or strategies or thinking or tool or tools or workshop$)).ti. [From ML1.7] (553) 2 (lean adj (approach or business model? or care or collaborat$ or design$ or enterpri?e or healthcare or health care or implementation? or industry or initiative? or intervention$ or leader$ or management or methodolog$ or method? or oncology or organi?ation$ or plan or planning or philosophy or practice or practices or principles or principle or process improvement? or production or program? or programme or programmes or quality or redesign$ or reengineer$ or restructur$ or reorgani$ or safety or sigma or strategy or strategies or thinking or tool or tools or workshop$)).ab. (347) 3 or/1-2 (511)

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Appendix 2: Data extraction form utilizing operational definition

Data Extraction Form: Minimum Criteria for Lean Management

Reviewer Name:

1

Has the organization or subunit of an organization (e.g. department or ward) made a continuing commitment to Lean philosophies?

Yes No Unclear

Source of Information (Page Number):

2 Did the intervention include at least one Lean assessment activity?

Yes No Unclear


3 Did the intervention include at least one Lean improvement activity?

Yes No Unclear


Eligibility: Criterion 1 must be "yes"

AND Criterion 2 OR Criterion 3 must be "yes"

Decision: Include Exclude

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Appendix 3: Reason for Exclusion

Study ID Reason

for Exclusion

Supporting Information (Quote Including Page

Number)

Justification of Exclusion Continuing

Commitment Lean Philosophy

Beard 2010 [20]

Did not meet criterion 1

"The decision to begin a project to reduce waiting times was made after the chief pharmacist attended a five-day course focusing on improving clinical systems using a range of Lean and other techniques" (pg. 369)

No evidence of a continuing commitment to the use of Lean management

Fischman 2010 [27]


"A 'Lean Six Sigma' methodology was used to define and measure the critical factors affecting efficiency and continuity of care in an internal medicine (IM) residency clinic" (pg. 202)


No evidence of commitment to Lean philosophies (e.g. reducing waste, improving flow, continuous improvement) within the organization

Harmelink 2008 [30]


"A performance improvement project was conducted by the department of radiology at St. Luke’s Regional Medical Center" (pg. 62) "This project was different. We needed to get the staff to embrace the idea in order to institute a culture” (pg. 62)


Kelly 2007 [32]


"The aim of this project was to analyse ED patient flow processes using a task analysis and Lean thinking approach, and re-engineer these processes to improve flow through the ED for all groups of patients" (pg. 16) "This project was undertaken in the ED of Western Hospital, a 300 bed, community teaching hospital in Melbourne, Australia" (pg. 16)



Van Lent 2009 [46]


"Like many healthcare improvement projects, this project is structured according to the Plan-Do-Study-Act cycle. This iterative method has much in common with clinical practice where ‘therapies are initiated under close observation and adjustments are made as data and experience accumulate’. The project lasted from 2005 until 2008, but we did not work full-time on it" (pg. 801)



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Yousri 2011 [49]


"A value-stream model (Lean thinking) was set to improve the outcome of fracture neck of femur patients at Goodhope Hospital, Heart of England Foundation NHS Trust" (pg. 1234)

No evidence of commitment to the use of Lean management before or after the project


Criterion 1: The organization or a subunit of an organization (e.g. department or ward) made a continuing commitment to Lean philosophies Criterion 2: The intervention included at least one Lean assessment activity Criterion 3: The intervention included at least one Lean improvement activity

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