Study Design. Retrospective cohort. Objective. We evaluate the correlation of the Patient-Reported Outcomes Measurement Information System for physical function (PROMIS-PF) with legacy patient-reported outcome measures (PROMs) in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) up to 2 years postoperatively. Summary of Background Data. PROMIS-PF has not been validated past 6 months following MIS TLIF. Methods. A surgical registry was retrospectively reviewed for eligible MIS TLIFs between May 2015 and September 2017. Inclusion criteria were primary, one- or two-level MIS TLIFs for degenerative spinal pathology. Patients without preoperative or 2-year follow up PROMIS-PF surveys were excluded. Demographic, perioperative, and PROMs including Visual Analog Scale (VAS) back, VAS leg, Oswestry Disability Index (ODI), 12-Item Short Form (SF-12) physical component summary (PCS) scores, and PROMIS-PF at preoperative and postoperative timepoint (e.g., 6 weeks, 12 weeks, 6 months, 1 year, and 2 years). A paired t test evaluated PROM improvement from baseline. The relationship of PROMIS-PF with VAS back, VAS leg, SF-12 PCS, and ODI was evaluated with a Pearson correlation coefficient. Results. The 68-subject cohort was 41.2% female, with an average age of 52.9 years; 44.1% were obese, and the majority underwent one-level fusions (95.6%). Pain (VAS back, VAS leg) and disability metrics (ODI) demonstrated significant improvement at all timepoints following MIS TLIF when compared to baseline (all P < 0.001). Physical function (SF-12 PCS, PROMIS-PF) demonstrated significant postoperative improvement at 12 weeks, 6 months, 1 year, and 2 years (all P < 0.001). All evaluated timepoints, with the exception of preoperative VAS back scores, revealed strong PROMIS-PF correlations with VAS back, VAS leg, ODI, and SF-12 PCS. Conclusion. PROMIS-PF demonstrated a strong correlation with pain (VAS back, VAS leg), disability (ODI) and physical function (SF-12) at all postoperative follow-ups through 2 years. Our study provides longitudinal evidence for utilizing PROMIS-PF as a valid physical function measure among patients undergoing MIS TLIF. Level of Evidence: 4.

Objective: To assess the impact of bilateral versus unilateral interbody cages on outcomes for minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) procedures.Methods: A retrospective review for primary, elective, single-level MIS TLIF procedures with bilateral posterior instrumentation from 2008–2020 was performed. Patients were grouped according to unilateral or bilateral interbody cage use. Procedures performed without static interbody cages or indicated for trauma, infection, malignancy were excluded. Patient-reported outcomes (PROs) included visual analogue scale (VAS), Oswestry Disability Index, 12-item Short Form health survey physical composite score (SF-12 PCS), PatientReported Outcome Measurement Information System physical function (PROMIS-PF). PROs were collected preoperatively and postoperatively. Change in PROs (Δ) was calculated and compared between groups. Achievement of minimum clinically important difference (MCID) was calculated using established values from the literature. Achievement rates were compared between groups using logistic regression.Results: The study included 151 patients, with 111 unilateral and 40 bilateral cage placements. Charlson Comorbidity Index, diabetes, and insurance status differed between groups (p < 0.050). Prevalence of degenerative and isthmic spondylolisthesis (both p ≤ 0.002), operative level (p = 0.003), and postoperative length of stay (p = 0.022) significantly differed between groups. The unilateral group had lower 1-year arthrodesis rates (p = 0.035). Preoperative VAS leg (p = 0.017) and SF-12 PCS (p = 0.045) were worse for the unilateral group. ΔPROMIS-PF was greater for the bilateral group at 2 years (p = 0.001). Majority of patients achieved an overall MCID for all PROs, except VAS leg (bilateral group).Conclusion: While preoperative status and postoperative arthrodesis rates differed, patients achieved an MCID at similar rates regardless of use of unilateral or bilateral cages.

Study Design: This was a retrospective cohort study. Objective: The purpose of this study is to examine whether the time duration from symptom onset to operative treatment is associated with postoperative clinical improvement after anterior cervical discectomy and fusion (ACDF). Summary of Background Data: There is a paucity of literature regarding the influence of preoperative symptom duration on patient-reported outcomes (PROs) following ACDF. Methods: Patients who underwent primary, single-level ACDF were retrospectively reviewed and stratified according to preoperative symptom duration (<12 and ≥12 mo). Demographic and perioperative characteristics were compared using χ2 analysis and linear regression. Subgroup mean scores were compared and achievement of minimal clinically important difference (MCID) was assessed for the Neck Disability Index (NDI), Visual Analogue Scale (VAS) neck pain, VAS arm pain, and 12-Item Short-Form Physical Component Score. Results: A total of 109 patients underwent primary, single-level ACDF: 68 had duration of symptoms (DOS) <12 months and 41 had a DOS ≥12 months. When comparing DOS subgroup preoperative PROs, there was no preoperative difference in NDI, VAS arm or neck pain, and 12-Item Short-Form Physical Component Score. In the postoperative period, there were no significant differences in the improvement of PROs throughout the 12-month timepoint. A significantly larger proportion of the <12 months DOS cohort achieved NDI MCID at the 3-month (66.1% vs. 43.8%, P=0.039) and 6-month (76.8% vs. 53.6%, P=0.030) postoperative period. Conclusions: Among the patient subgroups with <12 and ≥12 months DOS, there were no statistically significant differences observed in any of the measured PRO means at any timepoint. When assessing MCID, however, patients with shorter DOS (<12 mo) were observed to attain NDI MCID at the 3- and 6-month timepoints more often than patients with DOS ≥12 months. Our findings suggest that delayed surgical intervention may impair functional recovery to MCID in patients with degenerative cervical disease.

Study Design. Retrospective cohort. Objective. To investigate and establish minimum clinically important differences (MCID) for Patient Health Questionnaire-9 (PHQ-9) among patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Summary of Background. Spine surgery is linked to postoperative improvements in anxiety, depression, and mental health. These improvements have been documented using patientreported outcome measures such as PHQ-9. Few studies evaluated the clinical significance of PHQ-9 for lumbar spine surgery. Methods. Patients who underwent single-level, primary MIS TLIF from 2015 to 2017 were retrospectively reviewed in a prospective database. Patients with incomplete preoperative and 2-year postoperative PHQ-9 surveys were excluded. Demographic and perioperative characteristics were recorded. PHQ-9, 12-Item Short Form (SF-12), and Veterans RAND 12-Item Health Survey (VR-12) Mental Component Summary (MCS) were collected at preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year intervals. MCID was calculated using anchor and distribution-based methods. SF-12 served as an anchor. MCID was assessed using mean change methodology, four receiver operating characteristic curve assessments, and standard error measurement. Cutoff values were selected from receiver operating characteristic curve analysis. MCID achievement rates for all patient-reported outcome measures were calculated. Results. A total of 139 patients met inclusion criteria, with a mean age of 55 years and 39% females. The most common spinal pathology was radiculopathy (92%). MCID analysis revealed the following ranges of values: 2.0 to 4.8 (PHQ-9), 6.7 to 12.1 (SF-12 MCS), and 7.5 to 15.9 (VR-12 MCS). Final MCID thresholds were 3.0 (PHQ-9), 9.1 (SF-12 MCS), and 8.1 (VR-12 MCS). MCID achievement at 2-years for PHQ-9, SF-12 MCS, and VR-12 MCS was 89.2%, 85.6%, and 84.9% respectively. Conclusion. Our 2-year postoperative MCID analysis is the first mental health calculation from an MIS TLIF cohort. We report a 2-year MCID value for PHQ-9 of 3.0 (2.0-4.8). MCID values for mental health instruments are important for determining overall success of lumbar spine surgery.

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OBJECTIVE The Physical Component Score of the Veterans RAND 12 Item Health Survey (VR-12 PCS) has been assessed for use at short-term and intermediate-term time points for lumbar fusion populations. This study assesses the long-term validity and establishes minimal clinically important difference (MCID) values of VR-12 PCS in patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). METHODS A surgical registry was retrospectively reviewed for primary, elective, single-level MIS TLIF procedures with posterior instrumentation. Patients missing preoperative and 2-year postoperative VR-12 PCS survey data were excluded. VR-12 PCS, SF-12 Health Survey Physical Component Summary (SF-12 PCS), Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS PF), and Oswestry Disability Index (ODI) patient-reported outcome measures (PROMs) were recorded preoperatively and postoperatively. Responsiveness of the VR-12 measure was assessed in two ways. First, the mean postoperative PROM scores were compared with preoperative baseline values using a paired Student t-test. Second, MCID values were calculated using both distribution-based and anchor-based methods and used to assess improvement in VR-12 score at the 2-year time point. Discriminant validity of the VR-12 was assessed using cross-sectional and longitudinal anchors. Convergent validity of the VR-12 measure was assessed using Pearson’s correlation coefficient and partial time-independent correlation. Floor and ceiling effects were assessed. RESULTS A total of 74 patients who underwent MIS TLIF were included. The VR-12 PCS demonstrated significant improvements at all time points from 12 weeks to 2 years (p < 0.001 for all). VR-12 PCSs were significantly different for patients classified using cross-sectional anchors (p < 0.001) and longitudinal anchors (p ≤ 0.005). Calculated MCID values ranged from 4.1 to 8.5, and 4.1 was selected as the optimal MCID, which 87.8% of patients achieved. Strong, significant correlations of the VR-12 PCS with SF-12 PCS and PROMIS PF were demonstrated at all time points (p < 0.001 for all). No significant floor or ceiling effects were detected. CONCLUSIONS The VR-12 PCS demonstrated excellent responsiveness, discriminant and convergent validity, and no significant floor or ceiling effects up to 2 years after MIS TLIF. Therefore, VR-12 PCS may serve as a valid measure of long-term physical function.

Objective: Our study aims to evaluate the impact of severity of preoperative Neck Disability Index (NDI) on postoperative patient-reported outcome measures (PROMs). Methods: A retrospective review of primary, elective, single or multilevel anterior cervical discectomy and fusion or cervical disc arthroplasty procedures between 2013 and 2019 was performed. Visual analogue scale (VAS) neck and arm, NDI, 12-item Short Form physical and mental composite score (SF-12 PCS and MCS), Patient-Reported Outcome Measurement Information System physical function, and 9-item Patient Health Questionnaire (PHQ-9) were collected preoperatively and postoperatively. Patients were categorized by preoperative NDI: none-to-mild disability ( < 30); moderate disability ( ≥ 30 to < 50); severe disability ( ≥ 50 to < 70); complete disability ( ≥ 70). The impact of preoperative NDI on PROM scores and minimum clinically important difference (MCID) achievement rates were evaluated. Results: The cohort included 74 patients with none-to-mild disability, 95 moderate, 76 severe, and 17 with complete disability. Patients with greater preoperative disability demonstrated significantly different scores for NDI, VAS neck, SF-12 MCS, and PHQ-9 at all timepoints (p < 0.001). Patients with more severe disability demonstrated different magnitudes of improvement for NDI (all p < 0.001), VAS neck (p ≤ 0.009), VAS arm (p = 0.025), and PHQ-9 (p ≤ 0.011). The effect of preoperative severity on MCID achievement was demonstrated for NDI and for PHQ-9 (p ≤ 0.007). Conclusion:Patients with severe neck disability demonstrated differences in pain, disability, physical and mental health. MCID achievement also differed by preoperative symptoms severity. Patients with more severe neck disability may be limited to the degree of improvement in quality of life but perceive them as significant changes.

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