Cited by 216Healthcare Quality and ManagementQuality and Supply ManagementManagement Systems and Quality Improvement

A critical review of the research literature on Six Sigma, Lean and StuderGroup's Hardwiring Excellence in the United States: the need to demonstrate and communicate the effectiveness of transformation strategies in healthcare

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Vest, Joshua R, Gamm, Larry D·2009·Implementation Science

Abstract

BACKGROUND: U.S. healthcare organizations are confronted with numerous and varied transformational strategies promising improvements along all dimensions of quality and performance. This article examines the peer-reviewed literature from the U.S. for evidence of effectiveness among three current popular transformational strategies: Six Sigma, Lean/Toyota Production System, and Studer's Hardwiring Excellence. METHODS: The English language health, healthcare management, and organizational science literature (up to December 2007) indexed in Medline, Web of Science, ABI/Inform, Cochrane Library, CINAHL, and ERIC was reviewed for studies on the aforementioned transformation strategies in healthcare settings. Articles were included if they: appeared in a peer-reviewed journal; described a specific intervention; were not classified as a pilot study; provided quantitative data; and were not review articles. Nine references on Six Sigma, nine on Lean/Toyota Production System, and one on StuderGroup meet the study's eligibility criteria. RESULTS: The reviewed studies universally concluded the implementations of these transformation strategies were successful in improving a variety of healthcare related processes and outcomes. Additionally, the existing literature reflects a wide application of these transformation strategies in terms of both settings and problems. However, despite these positive features, the vast majority had methodological limitations that might undermine the validity of the results. Common features included: weak study designs, inappropriate analyses, and failures to rule out alternative hypotheses. Furthermore, frequently absent was any attention to changes in organizational culture or substantial evidence of lasting effects from these efforts. CONCLUSION: Despite the current popularity of these strategies, few studies meet the inclusion criteria for this review. Furthermore, each could have been improved substantially in order to ensure the validity of the conclusions, demonstrate sustainability, investigate changes in organizational culture, or even how one strategy interfaced with other concurrent and subsequent transformation efforts. While informative results can be gleaned from less rigorous studies, improved design and analysis can more effectively guide healthcare leaders who are motivated to transform their organizations and convince others of the need to employ such strategies. Demanding more exacting evaluation of projects consultants, or partnerships with health management researchers in academic settings, can support such efforts.

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  • It is possible that a publication bias, not universally positive effects of Lean, is behind the lack of null and negative results.

    “It is possible that a publication bias, not universally positive effects of Lean, is behind the lack of null and negative results [22].”

    From Lean Thinking in Emergency Departments: A Critical Review (2011) · cites this paper as [22]

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Research works printed but not linked: 2

  1. Hansen BG Reducing nosocomial urinary tract infections through process improvement Journal for Healthcare Quality: Promoting Excellence in Healthcare 2006 28 W2 2
  2. Pawson R Tilley N Realistic Evaluation 1997 Thousand Oaks, CA: Sage Publications Ltd

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Authors
Vest, J. R., & Gamm, L. D.
Affiliations
Texas A&M Health Science Center (US)
Corresponding author
Vest, Joshua R
Venue
Implementation Science
Published
2009-07-01
Volume
4
Issue
1
Pages
35-35
ISSN
1748-5908 (ISSN-L)
OpenAlex
W2165028684
Cited by
216
References
57
Citations by year
2026: 2 · 2025: 5 · 2024: 3 · 2023: 5 · 2022: 6 · 2021: 10 · 2020: 14 · 2019: 21 · 2018: 18 · 2017: 11 · 2016: 20 · 2015: 21 · 2014: 22 · 2013: 12 · 2012: 18
FWCI
32.44
Type
journal article
Language
en
Open access
Locations
  • Implementation Science (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (acceptedVersion)
  • OakTrust (Texas A&M University Libraries) (submittedVersion)
Topics
  • Health Sciences › Health Professions › Health Information Management › Healthcare Quality and Management
  • Social Sciences › Business, Management and Accounting › Management Information Systems › Quality and Supply Management
  • Social Sciences › Business, Management and Accounting › Strategy and Management › Management Systems and Quality Improvement
Keywords
Six Sigma, lean manufacturing, Toyota Production System, healthcare transformation, quality improvement strategies, evidence of effectiveness, methodological limitations, organizational culture change, sustainability of improvement, quality of care

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