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The Role of Potentially Modifiable Factors in a Standard Work Protocol to Decrease Complications in Adult Spinal Deformity Surgery: A Systematic Review, Part 1

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Abstract

Study Design

Structured Literature Review.

Objectives

We sought to evaluate the peer-reviewed literature for potentially modifiable patient and surgical factors that could be incorporated into a Standard Work protocol to decrease complications in adult spinal deformity (ASD) surgery.

Summary of Background Data

Lean Methodology uses Standard Work to improve efficiency and decrease waste and error. ASD is known to have a high surgical complication rate. Several patient and surgical potentially modifiable factors have been suggested to affect complications, including preoperative hemoglobin, bone density, body mass index (BMI), age-appropriate realignment, preoperative albumin/prealbumin, and smoking status. We sought to evaluate the literature for evidence supporting these factors to include in a Standard Work protocol to decrease complications.

Methods

Each of these six factors was developed into an appropriate clinical question that included the patient population, surgical intervention, a comparison group, and outcomes measure (PICO question). A comprehensive literature search was then performed. The authors reviewed abstracts and analyzed data from included studies. From 456 initial citations with abstract, 173 articles underwent full-text review. The best available evidence for clinical questions regarding the influence of these factors was provided by 93 included studies.

Results

We found fair evidence supporting a low preoperative hemoglobin level associated with increased transfusion rates and decreased BMD and increased BMI associated with increased complication rates. Fair evidence supported low albumin/prealbumin associated with increased complications. There was fair evidence associating smoking exposure to increased reoperations, but conflicting evidence associating it with increased complications. There was no evidence in the literature evaluating age-appropriate realignment and complications.

Conclusion

Preoperative hemoglobin, bone density, body mass index, preoperative albumin/prealbumin, and smoking status all are potentially modifiable risk factors that are associated with increased complications in the adult spine surgery population. Developing a Standard Work Protocol for patient evaluation and optimization should include these factors.

Level of Evidence

Level II.

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Author information

Authors and Affiliations

  1. Department of Orthopedic Surgery, University of Kansas Medical Center, 3901 Rainbow Boulevard, 66160, Kansas City, KS, USA

    Douglas C. Burton MD

  2. Neuroscience Institute, Virginia Mason Hospital, 1100 Ninth Avenue, 98101, Seattle, WA, USA

    Rajiv K. Sethi MD & Anna K. Wright PhD

  3. Department of Health Services, University of Washington, NE Pacific Street, 98195, Seattle, WA, USA

    Rajiv K. Sethi MD

  4. Department of Orthopedics, Brown University, 222 Richmond Street, 02912, Providence, RI, USA

    Alan H. Daniels MD & Daniel B. Reid MD

  5. Department of Neurological Surgery, University of California San Francisco, 513 Parnassus Avenue, 94131, San Francisco, CA, USA

    Christopher P. Ames MD

  6. Department of Orthopedic Surgery, University of California, 1 Shields Avenue, 95616, Davis, CA, USA

    Eric O. Klineberg MD & Robert Harper MD

  7. San Diego Spine Foundation, 6190 Cornerstone Ct. E, Suite 212, 92121, San Diego, CA, USA

    Gregory M. Mundis MD

  8. Department of Neurosurgery, Barrow Neurological Institute, St. Joseph’s Hospital and Medical Center, 85013, Phoenix, AZ, USA

    Randall J. Hlubek MD

  9. Denver International Spine Center, Presbyterian St. Luke’s Medical Center, Rocky Mountain Hospital for Children, 2055 High Street, Suite 130, 80205, Denver, CO, USA

    Shay Bess MD

  10. Swedish Neuroscience Institute, 550 17th Avenue, Suite 540, 98122, Seattle, WA, USA

    Robert A. Hart MD

  11. Department of Orthopaedics, Washington University St. Louis, 1 Brookings Dr., 63130, St. Louis, MO, USA

    Michael P. Kelly MD

  12. Department of Orthopedic Surgery, Columbia University, Och Spine Hospital, 5141 Broadway, 10034, New York, NY, USA

    Lawrence G. Lenke MD

Authors
  1. Douglas C. Burton MD
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  2. Rajiv K. Sethi MD
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  3. Anna K. Wright PhD
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  4. Alan H. Daniels MD
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  5. Christopher P. Ames MD
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  6. Daniel B. Reid MD
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  7. Eric O. Klineberg MD
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  8. Robert Harper MD
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  9. Gregory M. Mundis MD
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  10. Randall J. Hlubek MD
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  11. Shay Bess MD
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  12. Robert A. Hart MD
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  13. Michael P. Kelly MD
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  14. Lawrence G. Lenke MD
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Corresponding author

Correspondence to Douglas C. Burton MD.

Additional information

Author disclosures: DCB (grants from Orthofix, during the conduct of the study; personal fees from DePuy and Allosource; grants from DePuy and Pfizer, outside the submitted work), RKS (none), AKW (none), AHD (grants and personal fees from Orthofix; personal fees from Stryker, EOS, and Spineart; other from Springer, outside the submitted work), CPA (personal fees from UCSF, Stryker, Biomet Zimmer Spine, DePuy Synthes, NuVasive, K2M, Medicrea, Medtronic, Biomet Zimmer, Titan Spine, International Spine Study Group [ISSG], Operative Neurosurgery, Scoliosis Research Society [SRS], and Global Spinal Analytics, outside the submitted work), DBR (none), EOK (personal fees from DePuy Synthes, Stryker, K2M, Springer, Trevena, and Allosource; grants and personal fees from AO Spine; personal fees from Medicrea, outside the submitted work), RH (none), GMM (personal fees from NuVasive, K2M, Allosource, Viseon, and SeaSpine, outside the submitted work; in addition, GMM has a patent NuVasive with royalties paid, and a patent K2M with royalties paid), RJH (none), SB (grants from NuVasive, Medtronic, Stryker Spine, Biomet Spine, and Orthofix; personal fees from K2 Medical, outside the submitted work), RAH (personal fees from Globus, Seaspine, and DePuy Synthes; grants from ISSGF; personal fees from Medtronic and Orthofix, outside the submitted work), MPK (grants from DePuy/Synthes Spine and AOSpine, outside the submitted work; in addition, MPK has a patent Pharmaceuticals pending), LGL (personal fees from Medtronic; grants and personal fees from DePuy-Synthes Spine; personal fees from K2M, Fox Rothschild, LLC, and Quality Medical Publishing; nonfinancial support from Broadwater, Seattle Science Foundation, Stryker Spine, and The Spinal Research Foundation; grants and nonfinancial support from Scoliosis Research Society and AOSpine; grants from EOS, Setting Scoliosis Straight Foundation; other from Evans Family Donation, Fox Family Foundation, outside the submitted work).

Funding: This study was supported by a grant from Orthofix.

IRB approval: This systematic review was void of PHI and received a formal determination of not involving human subjects per 45CFR 46.102(f).

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Burton, D.C., Sethi, R.K., Wright, A.K. et al. The Role of Potentially Modifiable Factors in a Standard Work Protocol to Decrease Complications in Adult Spinal Deformity Surgery: A Systematic Review, Part 1. Spine Deform 7, 669–683 (2019). https://doi.org/10.1016/j.jspd.2019.04.003

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  • DOI: https://doi.org/10.1016/j.jspd.2019.04.003

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