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Published in: Implementation Science 1/2009

Open Access 01-12-2009 | Systematic Review

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

Authors: Joshua R Vest, Larry D Gamm

Published in: Implementation Science | Issue 1/2009

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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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Literature
1.
go back to reference Institute of Medicine: Crossing the Quality Chasm: a new health system for the 21st century. 2001, Washington, D.C.: National Academy Press Institute of Medicine: Crossing the Quality Chasm: a new health system for the 21st century. 2001, Washington, D.C.: National Academy Press
2.
go back to reference Bush RW: Reducing waste in US health care systems. JAMA. 2007, 297: 871-874. 10.1001/jama.297.8.871.CrossRefPubMed Bush RW: Reducing waste in US health care systems. JAMA. 2007, 297: 871-874. 10.1001/jama.297.8.871.CrossRefPubMed
3.
go back to reference King WR: Organizational transformation. Information Systems Management. 1997, 14: 63-65. 10.1080/10580539708907047.CrossRef King WR: Organizational transformation. Information Systems Management. 1997, 14: 63-65. 10.1080/10580539708907047.CrossRef
4.
go back to reference Levy A, Merry U: Organizational Transformation: approaches, strategies, theories. 1986, New York: Praeger Publishers Levy A, Merry U: Organizational Transformation: approaches, strategies, theories. 1986, New York: Praeger Publishers
5.
go back to reference Nutt PC, Backoff RW: Organizational Transformation. Journal of Management Inquiry. 1997, 6: 235-254. 10.1177/105649269763009.CrossRef Nutt PC, Backoff RW: Organizational Transformation. Journal of Management Inquiry. 1997, 6: 235-254. 10.1177/105649269763009.CrossRef
6.
go back to reference Van Tonder C: 'Organisational transformation': wavering on the edge of ambiguity. SA Journal of Industrial Psychology. 2004, 30: 53-64. Van Tonder C: 'Organisational transformation': wavering on the edge of ambiguity. SA Journal of Industrial Psychology. 2004, 30: 53-64.
7.
go back to reference Gersick CJG: Revolutionary Change Theories: A Multilevel Exploration of the Punctuated Equilibrium Paradigm. The Academy of Management Review. 1991, 16: 10-36. 10.2307/258605.CrossRef Gersick CJG: Revolutionary Change Theories: A Multilevel Exploration of the Punctuated Equilibrium Paradigm. The Academy of Management Review. 1991, 16: 10-36. 10.2307/258605.CrossRef
8.
go back to reference Tushman ML, Anderson P: Technological discontinuities and organizational environments. Administrative Science Quarterly. 1986, 31: 439-465. 10.2307/2392832.CrossRef Tushman ML, Anderson P: Technological discontinuities and organizational environments. Administrative Science Quarterly. 1986, 31: 439-465. 10.2307/2392832.CrossRef
10.
go back to reference Walston SL, Bogue RJ, Schwartz MJ: The effects of reengineering: fad or competitive factor?. Journal of Healthcare Management. 1998, 44: 456-476. Walston SL, Bogue RJ, Schwartz MJ: The effects of reengineering: fad or competitive factor?. Journal of Healthcare Management. 1998, 44: 456-476.
11.
go back to reference Gamm L, Kash B, Bolin J: Organizational technologies for transforming care: measures and strategeis for pursuit of IOM quality aims. Journal of Ambulatory Care Management. 2007, 30: 291-301.CrossRefPubMed Gamm L, Kash B, Bolin J: Organizational technologies for transforming care: measures and strategeis for pursuit of IOM quality aims. Journal of Ambulatory Care Management. 2007, 30: 291-301.CrossRefPubMed
12.
go back to reference Bigelow B, Arndt M: The more things change, the more they stay the same. Health Care Manage Rev. 2000, 25: 65-72.CrossRefPubMed Bigelow B, Arndt M: The more things change, the more they stay the same. Health Care Manage Rev. 2000, 25: 65-72.CrossRefPubMed
13.
go back to reference Bazzoli GJ, Dynan L, Burns LR, Yap C: Two decades of organizational change in health care: what have we learned?. Med Care Res Rev. 2004, 61: 247-331. 10.1177/1077558704266818.CrossRefPubMed Bazzoli GJ, Dynan L, Burns LR, Yap C: Two decades of organizational change in health care: what have we learned?. Med Care Res Rev. 2004, 61: 247-331. 10.1177/1077558704266818.CrossRefPubMed
14.
go back to reference Mantone J: Successful succession. Modern Healthcare. 2004, 34: 28-29. Mantone J: Successful succession. Modern Healthcare. 2004, 34: 28-29.
15.
go back to reference Sherman J: Achieving REAL Results with Six Sigma. Healthcare Executive. 2006, 21: 8-14.PubMed Sherman J: Achieving REAL Results with Six Sigma. Healthcare Executive. 2006, 21: 8-14.PubMed
16.
go back to reference Serrano L, Slunecka FW: Lean processes improve patient care. Healthcare Executive. 2006, 21: 36-38.PubMed Serrano L, Slunecka FW: Lean processes improve patient care. Healthcare Executive. 2006, 21: 36-38.PubMed
18.
go back to reference Linderman K, Schroeder RG, Zaheer S, Choo AS: Six Sigma: a goal-theoretic perspective. Journal of Operations Management. 2003, 21: 193-203. 10.1016/S0272-6963(02)00087-6.CrossRef Linderman K, Schroeder RG, Zaheer S, Choo AS: Six Sigma: a goal-theoretic perspective. Journal of Operations Management. 2003, 21: 193-203. 10.1016/S0272-6963(02)00087-6.CrossRef
20.
go back to reference Barry R, Murcko A, Brubaker C: The Six Sigma Book for Healthcare: Improving Outcomes by Reducing Errors. 2002, Chicago, Il: Health Administration Press Barry R, Murcko A, Brubaker C: The Six Sigma Book for Healthcare: Improving Outcomes by Reducing Errors. 2002, Chicago, Il: Health Administration Press
21.
go back to reference Brady JE, Allen TT: Six Sigma literature: a review and agenda for future research. Quailty and Reliability engineering International. 2006, 22: 335-367. 10.1002/qre.769.CrossRef Brady JE, Allen TT: Six Sigma literature: a review and agenda for future research. Quailty and Reliability engineering International. 2006, 22: 335-367. 10.1002/qre.769.CrossRef
22.
go back to reference Adams R, Warner P, Hubbard B, Goulding T: Decreasing turnaround time between general surgery cases: a six sigma initiative. J Nurs Adm. 2004, 34: 140-148. 10.1097/00005110-200403000-00007.CrossRefPubMed Adams R, Warner P, Hubbard B, Goulding T: Decreasing turnaround time between general surgery cases: a six sigma initiative. J Nurs Adm. 2004, 34: 140-148. 10.1097/00005110-200403000-00007.CrossRefPubMed
23.
go back to reference Bush SH, Lao MR, Simmons KL, Goode JH, Cunningham SA, Calhoun BC: Patient access and clinical efficiency improvement in a resident hospital-based women's medicine center clinic. Am J Manag Care. 2007, 13: 686-690.PubMed Bush SH, Lao MR, Simmons KL, Goode JH, Cunningham SA, Calhoun BC: Patient access and clinical efficiency improvement in a resident hospital-based women's medicine center clinic. Am J Manag Care. 2007, 13: 686-690.PubMed
24.
go back to reference Eldridge NE, Woods SS, Bonello RS, Clutter K, Ellingson L, Harris MA, Livingston BK, Bagian JP, Danko LH, Dunn EJ: Using the six sigma process to implement the Centers for Disease Control and Prevention Guideline for Hand Hygiene in 4 intensive care units. J Gen Intern Med. 2006, 21 (Suppl 2): S35-42. 10.1007/s11606-006-0273-y.CrossRefPubMedPubMedCentral Eldridge NE, Woods SS, Bonello RS, Clutter K, Ellingson L, Harris MA, Livingston BK, Bagian JP, Danko LH, Dunn EJ: Using the six sigma process to implement the Centers for Disease Control and Prevention Guideline for Hand Hygiene in 4 intensive care units. J Gen Intern Med. 2006, 21 (Suppl 2): S35-42. 10.1007/s11606-006-0273-y.CrossRefPubMedPubMedCentral
25.
go back to reference Parker BM, Henderson JM, Vitagliano S, Nair BG, Petre J, Maurer WG, Roizen MF, Weber M, DeWitt L, Beedlow J: Six sigma methodology can be used to improve adherence for antibiotic prophylaxis in patients undergoing noncardiac surgery. Anesth Analg. 2007, 104: 140-146. 10.1213/01.ane.0000250371.76725.2e.CrossRefPubMed Parker BM, Henderson JM, Vitagliano S, Nair BG, Petre J, Maurer WG, Roizen MF, Weber M, DeWitt L, Beedlow J: Six sigma methodology can be used to improve adherence for antibiotic prophylaxis in patients undergoing noncardiac surgery. Anesth Analg. 2007, 104: 140-146. 10.1213/01.ane.0000250371.76725.2e.CrossRefPubMed
26.
go back to reference Volland J: Quality Intervenes At a Hospital. Quality Progress. 2005, 38: 57- Volland J: Quality Intervenes At a Hospital. Quality Progress. 2005, 38: 57-
27.
go back to reference Frankel HL, Crede WB, Topal JE, Roumanis SA, Devlin MW, Foley AB: Use of corporate Six Sigma performance-improvement strategies to reduce incidence of catheter-related bloodstream infections in a surgical ICU. J Am Coll Surg. 2005, 201: 349-358. 10.1016/j.jamcollsurg.2005.04.027.CrossRefPubMed Frankel HL, Crede WB, Topal JE, Roumanis SA, Devlin MW, Foley AB: Use of corporate Six Sigma performance-improvement strategies to reduce incidence of catheter-related bloodstream infections in a surgical ICU. J Am Coll Surg. 2005, 201: 349-358. 10.1016/j.jamcollsurg.2005.04.027.CrossRefPubMed
28.
go back to reference Elberfeld A, Goodman K, Van Kooy M: Using the Six Sigma approach to meet quality standards for cardiac medication administration. Journal of Clinical Outcomes Management. 2004, 11: 510-516. Elberfeld A, Goodman K, Van Kooy M: Using the Six Sigma approach to meet quality standards for cardiac medication administration. Journal of Clinical Outcomes Management. 2004, 11: 510-516.
29.
go back to reference Hansen BG: Reducing nosocomial urinary tract infections through process improvement. Journal for Healthcare Quality: Promoting Excellence in Healthcare. 2006, 28: W2-2. Hansen BG: Reducing nosocomial urinary tract infections through process improvement. Journal for Healthcare Quality: Promoting Excellence in Healthcare. 2006, 28: W2-2.
30.
go back to reference Fairbanks CB: Using six sigma and lean methodologies to improve or throughput. AORN Journal. 2007, 86: 73-82. 10.1016/j.aorn.2007.06.011.CrossRefPubMed Fairbanks CB: Using six sigma and lean methodologies to improve or throughput. AORN Journal. 2007, 86: 73-82. 10.1016/j.aorn.2007.06.011.CrossRefPubMed
31.
go back to reference Liker JK, Meier D: The Toyota Way Fieldbook. 2006, New York: McGraw-Hill Liker JK, Meier D: The Toyota Way Fieldbook. 2006, New York: McGraw-Hill
32.
go back to reference Bryant PM, Gulling RD: Faster, better, cheaper: lean labs are the key to future survival. Clin Leadersh Manag Rev. 2006, 20: E2-PubMed Bryant PM, Gulling RD: Faster, better, cheaper: lean labs are the key to future survival. Clin Leadersh Manag Rev. 2006, 20: E2-PubMed
33.
go back to reference Napoles L, Quintana M: Developing a lean culture in the laboratory. Clin Leadersh Manag Rev. 2006, 20: E4-PubMed Napoles L, Quintana M: Developing a lean culture in the laboratory. Clin Leadersh Manag Rev. 2006, 20: E4-PubMed
34.
go back to reference Persoon TJ, Zaleski S, Frerichs J: Improving preanalytic processes using the principles of lean production (Toyota Production System). Am J Clin Pathol. 2006, 125: 16-25.CrossRefPubMed Persoon TJ, Zaleski S, Frerichs J: Improving preanalytic processes using the principles of lean production (Toyota Production System). Am J Clin Pathol. 2006, 125: 16-25.CrossRefPubMed
35.
go back to reference Raab SS, Grzybicki DM, Sudilovsky D, Balassanian R, Janosky JE, Vrbin CM: Effectiveness of Toyota process redesign in reducing thyroid gland fine-needle aspiration error. Am J Clin Pathol. 2006, 126: 585-592. 10.1309/NJQ1L7KA10UKV93Q.CrossRefPubMed Raab SS, Grzybicki DM, Sudilovsky D, Balassanian R, Janosky JE, Vrbin CM: Effectiveness of Toyota process redesign in reducing thyroid gland fine-needle aspiration error. Am J Clin Pathol. 2006, 126: 585-592. 10.1309/NJQ1L7KA10UKV93Q.CrossRefPubMed
36.
go back to reference Zarbo RJ, D'Angelo R: The Henry Ford production system – Effective reduction of process defects and waste in surgical pathology. American Journal of Clinical Pathology. 2007, 128: 1015-1022. 10.1309/RGF6JD1NAP2DU88Q.CrossRefPubMed Zarbo RJ, D'Angelo R: The Henry Ford production system – Effective reduction of process defects and waste in surgical pathology. American Journal of Clinical Pathology. 2007, 128: 1015-1022. 10.1309/RGF6JD1NAP2DU88Q.CrossRefPubMed
37.
go back to reference Nelson-Peterson DL, Leppa CJ: Creating an environment for caring using lean principles of the Virginia Mason Production System. J Nurs Adm. 2007, 37: 287-294. 10.1097/01.NNA.0000277717.34134.a9.CrossRefPubMed Nelson-Peterson DL, Leppa CJ: Creating an environment for caring using lean principles of the Virginia Mason Production System. J Nurs Adm. 2007, 37: 287-294. 10.1097/01.NNA.0000277717.34134.a9.CrossRefPubMed
38.
go back to reference Raab SS, Andrew-JaJa C, Condel JL, Dabbs DJ: Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods. American Journal of Obstetrics and Gynecology. 2006, 194: 57-64. 10.1016/j.ajog.2005.06.069.CrossRefPubMed Raab SS, Andrew-JaJa C, Condel JL, Dabbs DJ: Improving Papanicolaou test quality and reducing medical errors by using Toyota production system methods. American Journal of Obstetrics and Gynecology. 2006, 194: 57-64. 10.1016/j.ajog.2005.06.069.CrossRefPubMed
39.
go back to reference Shannon RP, Frndak D, Grunden N, Lloyd JC, Herbert C, Patel B, Cummins D, Shannon AH, O'Neill PH, Spear SJ: Using real-time problem solving to eliminate central line infections. Jt Comm J Qual Patient Saf. 2006, 32: 479-487.PubMed Shannon RP, Frndak D, Grunden N, Lloyd JC, Herbert C, Patel B, Cummins D, Shannon AH, O'Neill PH, Spear SJ: Using real-time problem solving to eliminate central line infections. Jt Comm J Qual Patient Saf. 2006, 32: 479-487.PubMed
40.
go back to reference Furman C, Caplan R: Applying the Toyota Production System: using a patient safety alert system to reduce error. Jt Comm J Qual Patient Saf. 2007, 33: 376-386.PubMed Furman C, Caplan R: Applying the Toyota Production System: using a patient safety alert system to reduce error. Jt Comm J Qual Patient Saf. 2007, 33: 376-386.PubMed
41.
go back to reference Meade CM, Bursell AL, Ketelsen L: Effects of nursing rounds: on patients' call light use, satisfaction, and safety. Am J Nurs. 2006, 106: 58-70. quiz 70-51.CrossRefPubMed Meade CM, Bursell AL, Ketelsen L: Effects of nursing rounds: on patients' call light use, satisfaction, and safety. Am J Nurs. 2006, 106: 58-70. quiz 70-51.CrossRefPubMed
42.
go back to reference Thor J, Lundberg J, Ask J, Olsson J, Carli C, Harenstam KP, Brommels M: Application of statistical process control in healthcare improvement: systematic review. Qual Saf Health Care. 2007, 16: 387-399. 10.1136/qshc.2006.022194.CrossRefPubMedPubMedCentral Thor J, Lundberg J, Ask J, Olsson J, Carli C, Harenstam KP, Brommels M: Application of statistical process control in healthcare improvement: systematic review. Qual Saf Health Care. 2007, 16: 387-399. 10.1136/qshc.2006.022194.CrossRefPubMedPubMedCentral
43.
go back to reference Rogers EM: Diffusion of Innovations. 2003, New York: Free Press, 5 Rogers EM: Diffusion of Innovations. 2003, New York: Free Press, 5
44.
go back to reference Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ: Publication and related biases. Health Technol Assess. 2000, 4: 1-115. Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ: Publication and related biases. Health Technol Assess. 2000, 4: 1-115.
45.
go back to reference Ramsay CR, Matowe L, Grilli R, Grimshaw JM, Thomas RE: Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies. International Journal of Technology Assessment in Health Care. 2003, 19: 613-623. 10.1017/S0266462303000576.CrossRefPubMed Ramsay CR, Matowe L, Grilli R, Grimshaw JM, Thomas RE: Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies. International Journal of Technology Assessment in Health Care. 2003, 19: 613-623. 10.1017/S0266462303000576.CrossRefPubMed
46.
go back to reference Kotter JP: Leading Change: why transformation efforts fail. Harvard Business Review. 1995, 73: 59-67. Kotter JP: Leading Change: why transformation efforts fail. Harvard Business Review. 1995, 73: 59-67.
47.
go back to reference Fine DJ: Toward the Evolution of a Newly Skilled Managerial Class for Healthcare Organizations. Frontiers of Health Services Management. 2006, 22: 31-35.PubMed Fine DJ: Toward the Evolution of a Newly Skilled Managerial Class for Healthcare Organizations. Frontiers of Health Services Management. 2006, 22: 31-35.PubMed
48.
go back to reference Pawson R, Tilley N: Realistic Evaluation. 1997, Thousand Oaks, CA: Sage Publications Ltd Pawson R, Tilley N: Realistic Evaluation. 1997, Thousand Oaks, CA: Sage Publications Ltd
49.
go back to reference Stock GN, McFadden KL, Gowen CR: Organizational culture, critical success factors, and the recduction of hospital errors. International Journal of Production Economics. 2007, 106: 368-392. 10.1016/j.ijpe.2006.07.005.CrossRef Stock GN, McFadden KL, Gowen CR: Organizational culture, critical success factors, and the recduction of hospital errors. International Journal of Production Economics. 2007, 106: 368-392. 10.1016/j.ijpe.2006.07.005.CrossRef
50.
go back to reference Kanji G, Sa PM: Sustaining healthcare excellence through performance measurement. Total Quality Management and Business Excellence. 2003, 14: 269-289. 10.1080/1478336032000046607.CrossRef Kanji G, Sa PM: Sustaining healthcare excellence through performance measurement. Total Quality Management and Business Excellence. 2003, 14: 269-289. 10.1080/1478336032000046607.CrossRef
51.
go back to reference Kovner AR, Rundall TG: Evidence-Based Management Reconsidered. Frontiers of Health Services Management. 2006, 22: 3-22.PubMed Kovner AR, Rundall TG: Evidence-Based Management Reconsidered. Frontiers of Health Services Management. 2006, 22: 3-22.PubMed
52.
go back to reference Shortell SM, Levin DZ, O'Brien JL, Hughes EF: Assessing the evidence on CQI: is the glass half empty or half full?. Hosp Health Serv Adm. 1995, 40: 4-24.PubMed Shortell SM, Levin DZ, O'Brien JL, Hughes EF: Assessing the evidence on CQI: is the glass half empty or half full?. Hosp Health Serv Adm. 1995, 40: 4-24.PubMed
Metadata
Title
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
Authors
Joshua R Vest
Larry D Gamm
Publication date
01-12-2009
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2009
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/1748-5908-4-35

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