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Establishing minimum clinically important difference for patient-reported outcome measures in patients undergoing lateral lumbar interbody fusion

  • Original Article - Spine - Other
  • Published:
Acta Neurochirurgica Aims and scope

Abstract

Background

The minimum clinically important difference (MCID) has not been established in lateral lumbar interbody fusion (LLIF). Our study aims to establish MCID for patient-reported outcome measures (PROMs) of physical function and pain for LLIF through anchor-based and distribution-based approaches.

Methods

Patients undergoing LLIF with preoperative and 6-month postoperative Oswestry Disability Index (ODI) scores were identified. PROMs of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF), 12-Item Short Form Physical Component Score (SF-12 PCS), Veterans RAND 12-Item Short Form Physical Component Score (VR-12 PCS), visual analog scale (VAS) back, and VAS leg were collected at preoperative and 6-month postoperative time points. Anchor-based MCID calculations were average change, minimal detectable change, change difference, receiver operating characteristic curve, and cross-sectional analysis using ODI as the anchor. Distribution-based calculations were standard error of measurement, reliable change index, effect size, and 0.5 ∗ ΔSD.

Results

Fifty patients were included. Anchor-based approaches MCID ranges were PROMIS-PF 1.1–9.6, SF-12 PCS 6.4–16.5, VR-12 PCS 5.9–12.9, VAS Back 1.4–4.6, and VAS Leg 1.3–4.3. The area under curve for receiver operating characteristics (ROC) analysis ranged from 0.63 to 0.71. Distribution-based MCID ranges were PROMIS-PF 1.4–4.5, SF-12 PCS 1.9–12.7, VR-12 PCS 2.0–6.6, VAS Back 0.4–1.4, and VAS Leg 0.5–2.0.

Conclusion

MCID thresholds varied widely depending on the calculation method. The closest to (0,1) ROC approach was the most clinically appropriate MCID calculation. The corresponding MCID values for LLIF were PROMIS-PF at 7.8, SF-12 PCS at 6.4, VR-12 PCS at 9.3, VAS Back at 4.6, and VAS Leg at 4.3.

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Abbreviations

ALIF:

Anterior lumbar interbody fusion

ANOVA:

Analysis of variance

ASA:

American Society of Anesthesiologists

AUC:

Area under curve

BMI:

Body mass index

CCI:

Charlson Comorbidity Index

HTI:

Health transition item

LLIF:

Lateral lumbar interbody fusion

MCID:

Minimum clinically important difference

ODI:

Oswestry Disability Index

OME:

Oral morphine equivalents

ORA:

Office of Regulatory Affairs

POD:

Postoperative day

PROMIS-PF:

Patient-Reported Outcomes Measurement Information System Physical Function

PROMs:

Patient-reported Outcome Measures

ROC:

Receiver operating characteristics

SD:

Standard deviation

SF-12 PCS:

12-Item Short Form Physical Component Score

TLIF:

Transforaminal lumbar interbody fusion

VAS:

Visual Analog Scale

VR-12 PCS:

Veterans RAND 12-Item Short Form Physical Component Score

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Author information

Authors and Affiliations

  1. Department of Orthopaedic Surgery, Rush University Medical Center, 1611 W. Harrison St., Suite #300, IL, 60612, Chicago, USA

    James W. Nie, Timothy J. Hartman, Keith R. MacGregor, Omolabake O. Oyetayo, Eileen Zheng & Kern Singh

Authors
  1. James W. Nie
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  2. Timothy J. Hartman
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  3. Keith R. MacGregor
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  4. Omolabake O. Oyetayo
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  5. Eileen Zheng
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  6. Kern Singh
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Contributions

James W. Nie: conceptualization, methodology, visualization, formal analysis, software, investigation, writing – original draft, writing – review & editing.

Timothy J. Hartman: conceptualization, methodology, visualization, formal analysis, software, investigation, writing – original draft, writing – review & editing.

Keith R. MacGregor: project administration, data curation, investigation, writing – review & editing.

Omolabake O. Oyetayo: project administration, data curation, investigation, writing – review & editing.

Eileen Zheng: project administration, data curation, investigation, writing – review & editing.

Kern Singh: conceptualization, methodology, supervision, resources, investigation, writing – review & editing.

Corresponding authors

Correspondence to Eileen Zheng or Kern Singh.

Ethics declarations

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Institutional Review Board (IRB) of Rush University Medical Center (ORA #14051301).

Informed consent

Informed consent was obtained from all individual participants included in the study.

Conflcit of interests

Kern Singh, MD, receives royalties from Zimmer Biomet, Stryker, RTI Surgical, Lippincott Williams and Wilkins, Thieme, Jaypee Publishing, and Slack Publishing. Kern Singh, MD, owns stock in Avaz Surgical LLC and Vital 5 LLC. Kern Singh, MD, holds a consulting position with Zimmer Biomet and K2M. Kern Singh, MD, holds board membership with Vital 5 LLC. Kern Singh, MD, is on the editorial board of Contemporary Spine Surgery. Kern Singh, MD, received a research grant from the Cervical Spine Research Society. Kern Singh, MD, holds board membership with TDi LLC and Minimally Invasive Spine Study Group and receives no compensation as board member. Kern Singh, MD, is on the editorial board of Orthopedics Today and Vertebral Columns and receives no compensation as member of the editorial board. Kern Singh, MD, is on the board of directors of Cervical Spine Research Society, International Society for the Advancements of Spine Surgery, and American Academy of Orthopaedic Surgeons and receives no compensation as member of the board of directors.

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Nie, J.W., Hartman, T.J., MacGregor, K.R. et al. Establishing minimum clinically important difference for patient-reported outcome measures in patients undergoing lateral lumbar interbody fusion. Acta Neurochir 165, 325–334 (2023). https://doi.org/10.1007/s00701-022-05428-y

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