What Can Legacy Patient-Reported Outcome Measures Tell Us About Participation Bias in Patient-Reported Outcomes Measurement Information System Scores Among Lumbar Spine Patients?

Conor P. Lynch,Elliot D.K. Cha,Caroline N. Jadczak,Shruthi Mohan,Cara E. Geoghegan,Kern Singh 대한척추신경외과학회 2022 Neurospine Vol.19 No.2

Objective: Patient-Reported Outcomes Measurement Information System (PROMIS) is a validated tool for assessing patient-reported outcomes in spine surgery. However, PROMIS is vulnerable to nonresponse bias. The purpose of this study is to characterize differences in patient-reported outcome measure scores between patients who do and do not complete PROMIS physical function (PF) surveys following lumbar spine surgery. Methods: A prospectively maintained database was retrospectively reviewed for primary, elective lumbar spine procedures from 2015 to 2019. Outcome measures for Patient Health Questionnaire-9 (PHQ-9), visual analogue scale (VAS) back & leg, Oswestry Disability Index (ODI), and 12-item Short Form health survey physical composite summary (SF-12 PCS) were recorded at both preoperative and postoperative (6 weeks, 12 weeks, 6 months, 1 year, 2 years) timepoints. Completion rates for PROMIS PF surveys were recorded and patients were categorized into groups based on completion. Differences in mean scores at each timepoint between groups was determined. Results: Eight hundred nine patients were included with an average age of 48.1 years. No significant differences were observed for all outcome measures between PROMIS completion groups preoperatively. Postoperative PHQ-9, VAS back, VAS leg, and ODI scores differed significantly between groups through 1 year (all p < 0.05). SF-12 PCS differed significantly only at 6 weeks (p = 0.003). Conclusion: Patients who did not complete PROMIS PF surveys had significantly poorer outcomes than those that did in terms of postoperative depressive symptoms, pain, and disability. This suggests that patients completing PROMIS questionnaires may represent a healthier cohort than the overall lumbar spine population.

Comorbidity Influence on Postoperative Outcomes Following Anterior Cervical Discectomy and Fusion

Elliot D.K. Cha,Conor P. Lynch,Caroline N. Jadczak,Shruthi Mohan,Cara E. Geoghegan,Kern Singh 대한척추신경외과학회 2021 Neurospine Vol.18 No.2

Objective: This study aims to detail the association between comorbidity burden and achieving minimum clinically important difference (MCID) following anterior cervical discectomy and fusion (ACDF). Methods: A prospective surgical registry was retrospectively reviewed. Patients with missing preoperative Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) were excluded. Patients were stratified by Charlson Comorbidity Index (CCI): no comorbidities=0 point; low CCI=1–2 points; high CCI=≥3 points. Demographic and perioperative characteristics were collected and evaluated for differences. Visual analogue scale (VAS), 12-item Short Form health survey (SF-12), and PROMIS PF were collected pre- and postoperatively and assessed for differences. Differences in achievement of MCID were compared using established values: VAS neck=2.6, VAS arm=4.1, NDI=8.5, SF-12 physical composite score (SF-12 PCS)=8.1, PROMIS PF=4.5. Results: One hundred twenty-five ACDF patients were included: 37 had no comorbidities, 64 with low CCI, and 24 with high CCI. Higher CCI groups were older, nonsmokers, diabetic, arthritic, hypertensive, and had cancer. Multilevel fusions, operative time, length of stay, and later discharge day were associated with high CCI. VAS neck differed preoperatively by group. SF-12 PCS and PROMIS PF were inversely associated with CCI groups. CCI did not impact achievement of MCID for all outcomes. A lower rate of reaching MCID was demonstrated at 3 months for SF-12 PCS. Conclusion: Regardless of comorbidity burden, patients undergoing ACDF for cervical pathology demonstrated a similar rate of achieving MCID for VAS neck, VAS arm, NDI, and PROMIS PF. Regardless of CCI score, ACDF can have a significant benefit for patients.

Meeting Patient Expectations or Achieving a Minimum Clinically Important Difference: Predictors of Satisfaction Among Lumbar Fusion Patients

Cha Elliot D. K.,Lynch Conor P.,Jadczak Caroline N.,Mohan Shruthi,Geoghegan Cara E.,Singh Kern 대한척추외과학회 2022 Asian Spine Journal Vol.16 No.4

Study Design: Retrospective cohort. Purpose: To investigate the impact of meeting a patient’s preoperative expectations for back or leg pain or the achievement of minimum clinically important difference (MCID) on patient satisfaction following lumbar fusion. Overview of Literature: Few studies have compared if MCID achievement or meeting preoperative expectations for pain reduction affects patient satisfaction. Methods: A surgical database was reviewed for eligible patients who underwent lumbar fusion. Patient satisfaction and Visual Analog Scale (VAS) for back and leg pain were the outcomes of interest. Meeting expectations was calculated as a difference of ≤0 between preoperative expectations and postoperative VAS scores. MCID achievement was calculated by comparing changes in VAS scores with established values. Meeting preoperative expectations or MCID achievement as predictors of patient satisfaction was evaluated using regression analysis. Results: A total of 134 patients were included in this study. Patients demonstrated significant improvements in VAS back and VAS leg (p<0.001). At 1 year, 56.4% of patients had their VAS back expectations met compared with 59.5% for VAS leg. Similarly, at 1 year, 77.3% and 71.3% of patients achieved MCID for VAS back and leg, respectively. Meeting expectations for VAS back was significantly associated with patient satisfaction at all postoperative timepoints; however, MCID achievement only demonstrated a significant association with patient satisfaction at 6 and 12 weeks (all, p≤0.024). Meeting VAS leg expectations and MCID achievement both demonstrated a significant association with patient satisfaction at all postoperative timepoints (all, p≤0.02). No differences between MCID achievement and meeting expectations as predictors of satisfaction were noted. Conclusions: The majority of patients achieved MCID and had their back and leg pain expectations met by 1 year. Both measures were significant predictors of patient satisfaction and suggest that MCID achievement may act as a suitable substitute for patient satisfaction.

Higher American Society of Anesthesiologists Classification Does Not Limit Safety or Improvement Following Minimally Invasive Transforaminal Lumbar Interbody Fusion

Conor P. Lynch,Elliot D.K. Cha,Cara E. Geoghegan,Caroline N. Jadczak,Shruthi Mohan,Kern Singh 대한척추신경외과학회 2022 Neurospine Vol.19 No.3

Objective: The American Society of Anesthesiologists (ASA) physical status classification has been used to risk stratify surgical candidates. Our study compares outcomes of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) procedures based on preoperative ASA physical status classification. Methods: A surgical registry was reviewed for primary, single-level MIS TLIF patients. Patients were categorized by preoperative ASA physical status classification: ASA I, ASA II, ASA III+. Perioperative complications were compared among groups. Patient-reported outcome measures (PROMs) for back pain, leg pain, physical function, and disability were recorded preoperatively and at 6-week, 12-week, 6-month, 1-year, and 2-year postoperative timepoints. PROM improvement from baseline (ΔPROM) and minimum clinically important difference (MCID) achievement was calculated for each timepoint and compared among groups. MCID achievement was determined as ΔPROMs that surpassed previously established MCID values. Results: Of the 487 patients, 64 had an ASA classification of I, whereas 336 had an ASA of II, and 87 had an ASA of III or greater. Rates of complications were not associated with ASA classification (all p > 0.050). Neither mean PROM scores nor ΔPROM scores were significantly associated with ASA classification at any timepoint (all p > 0.050). MCID achievement was significantly associated with ASA classification for back pain at 1 year only (p = 0.041). Overall MCID achievement was not significantly associated with ASA classification for any PROM (p > 0.050). Conclusion: While ASA classification has been commonly used to risk stratify surgical candidates for spinal procedures, patients with an ASA of III or greater may be able to achieve similar long-term outcomes following MIS TLIF given proper selection criteria.

Preoperative Neck Disability Severity Limits Extent of Postoperative Improvement Following Cervical Spine Procedures

Elliot D.K. Cha,Conor P. Lynch,Shruthi Mohan,Cara E. Geoghegan,Caroline N. Jadczak,Kern Singh 대한척추신경외과학회 2021 Neurospine Vol.18 No.2

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.

Effects of Anterior Plating on Achieving Clinically Meaningful Improvement Following Single-Level Anterior Cervical Discectomy and Fusion

Conor P. Lynch,Elliot D.K. Cha,Madhav R. Patel,Caroline N. Jadczak,Shruthi Mohan,Cara E. Geoghegan,Kern Singh 대한척추신경외과학회 2022 Neurospine Vol.19 No.2

Objective: The clinical utility of anterior cervical plating for anterior cervical discectomy and fusion (ACDF) procedures remains controversial. This study aims to compare the impact of cervical plating on achievement of minimum clinically important difference (MCID) up to 2 years following ACDF. Methods: Patients undergoing primary, single-level ACDF procedures were grouped based on whether their procedure included application of an anterior cervical plate. Demographics, preoperative spinal diagnoses, operative characteristics, and patient-reported outcome measures (PROMs) were compared between plating groups. Achievement of an MCID was assessed using the following previously established thresholds: 12-item Short Form health survey physical component summary (SF-12 PCS) 8.1, visual analogue scale (VAS) neck 2.6, VAS arm 4.1, Neck Disability Index (NDI) 8.5. Rates of MCID achievement were compared between groups. Results: The cohort included 192 patients of whom 102 received plating and 90 received no plating. Plating status was significantly associated with Charlson Comorbidity Index and insurance status. Operative duration and estimated blood loss were significantly greater for the plating group. Both groups demonstrated significant improvements at the majority of postoperative timepoints. Significant intergroup differences in PROM improvement were demonstrated for VAS neck and NDI at 6 weeks. Rates of MCID achievement differed significantly between groups for NDI at 6 weeks, and 12 weeks, and SF-12 PCS overall. Conclusion: Patients improved significantly in terms of pain, disability and physical function, regardless of plating status, and with the exception of early neck pain and disability, these improvements were similar between groups. Patients that underwent plating as part of their ACDF procedure achieved an MCID for physical function at lower rates overall.

The Influence of Preoperative Narcotic Consumption on Patient-Reported Outcomes of Lumbar Decompression

Lynch Conor P.,Cha Elliot D. K.,Mohan Shruthi,Geoghegan Cara E.,Jadczak Caroline N.,Singh Kern 대한척추외과학회 2022 Asian Spine Journal Vol.16 No.2

Study Design: Retrospective cohort. Purpose: This study aimed to assess the relationship between preoperative narcotic consumption and patient-reported outcomes (PRO) in patients undergoing minimally invasive (MIS) lumbar decompression (LD). Overview of Literature: Previous studies report negative effects of narcotic consumption on perioperative outcomes and recovery; however, its impact on quality of life and surgical outcomes is not fully understood. Methods: A surgical database was retrospectively reviewed for patients undergoing primary, single-level MIS LD from 2013 to 2020. Patients lacking preoperative narcotic consumption data were excluded. Demographics, spinal pathologies, and operative characteristics were collected. Patients were grouped based on preoperative narcotic consumption. Patient Health Questionnaire-9 (PHQ-9), Visual Analog Scale (VAS) for back and leg, Oswestry Disability Index (ODI), 12-item Short Form Physical Component Summary, and Patient-Reported Outcomes Measurement Information System physical function (PROMIS-PF) were collected preoperatively and postoperatively. Preestablished values were used to calculate achievement of minimum clinically important difference (MCID). Differences in mean PROs and MCID achievement between groups were evaluated. Results: The cohort was 453 patients; 184 used preoperative narcotics and 269 did not. Significant differences were found in American Society of Anesthesiologists classification, ethnicity, insurance type, and estimated blood loss between groups. Significant differences were also found in preoperative PHQ-9, VAS leg, ODI, and PROMIS-PF between groups (all p<0.05). Mean postoperative PROs did not differ by group (p>0.05). A higher rate of MCID achievement was associated with the narcotic group for PHQ-9 and PROMIS-PF at 6 weeks (both p≤0.050), VAS leg at 1 year (p=0.009), and overall for ODI and PHQ-9 (both p≤0.050). Conclusions: Preoperative narcotic consumption was associated with worse preoperative depression, leg pain, disability, and physical function. In patients consuming preoperative narcotics, a higher proportion achieved an overall MCID for disability and depressive symptoms. Patients taking preoperative narcotic medications may report significantly worse preoperative PROs but demonstrate greater improvements in postoperative disability and mental health.

Outcomes of Transforaminal Lumbar Interbody Fusion Using Unilateral Versus Bilateral Interbody Cages

Conor P. Lynch,Elliot D.K. Cha,Augustus J. Rush III,Caroline N. Jadczak,Shruthi Mohan,Cara E. Geoghegan,Kern Singh 대한척추신경외과학회 2021 Neurospine Vol.18 No.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), Patient-Reported 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.

Patient-Reported Outcomes Measurement Information System Physical Function Validation for Use in Anterior Cervical Discectomy and Fusion: A 2-Year Follow-up Study

James M. Parrish,Nathaniel W. Jenkins,Elliot D.K. Cha,Conor P. Lynch,Cara E. Geoghegan,Shruthi Mohan,Caroline N. Jadczak,David P. Matichak,Kern Singh 대한척추신경외과학회 2021 Neurospine Vol.18 No.1

Objective: Our study aims to evaluate the correlation of Patient-Reported Outcomes Measurement Information System physical function (PROMIS PF) with legacy patient-reported outcome measures (PROMs) among patients undergoing anterior cervical discectomy and fusion (ACDF). Methods: A prospectively maintained database was retrospectively reviewed for ACDF surgeries performed between May 2015 and September 2017. Inclusion criteria were primary elective, single- or multilevel ACDFs for degenerative spinal pathology. Patients lacking preoperative or 2-year PROMIS PF surveys were excluded. Mean scores were calculated for visual analogue scale (VAS) neck, VAS arm, Neck Disability Index (NDI), 12-Item Short Form Physical Component Score (SF-12 PCS), and PROMIS PF at preoperative and 6-week, 12-week, 6-month, 1-year, and 2-year postoperative timepoints. A t-test and Pearson correlation coefficient were utilized to evaluate score improvement and PROM relationships respectively. Results: The 50 subject cohort was 60.0% male, 50% obese (body mass index≥30 kg/m2) and had an average age of 50.9 years. Significant improvements were demonstrated for VAS neck and NDI at all postoperative timepoints (p<0.001) and for SF-12 and PROMIS PF at all timepoints except 6 weeks (p≤0.025). VAS arm improvement was seen up to 1 year (p≤0.016). PROMIS PF demonstrated strong correlations with NDI and SF-12 PCS at all evaluated timepoints and with VAS neck at all postoperative timepoints except 6 weeks (all p<0.01). Conclusion: PROMIS PF was strongly correlated with pain, disability, and physical function up to 2 years for patients undergoing ACDF. Our results support the long-term validity of PROMIS PF for measurement of patient-reported physical function among ACDF cohorts.

Role of Gender in Improvement of Depressive Symptoms Among Patients Undergoing Cervical Spine Procedures

Elliot D.K. Cha,Conor P. Lynch,James M. Parrish,Nathaniel W. Jenkins,Cara E. Geoghegan,Caroline N. Jadczak,Shruthi Mohan,Kern Singh 대한척추신경외과학회 2021 Neurospine Vol.18 No.1

Objective: There is a scarcity of research evaluating gender differences in depressive symptoms among patients undergoing cervical surgery. This study investigated gender differences with regard to depressive symptom severity, measured by Patient Health Questionnaire-9 (PHQ-9), in patients following anterior cervical discectomy and fusion (ACDF) or artificial disc replacement (ADR). Methods: A prospectively maintained surgical registry was retrospectively reviewed for eligible spine surgeries. Depressive symptom severity was evaluated by PHQ-9 at both pre- and postoperative timepoints (e.g., 6 weeks, 12 weeks, 6 months, 1 year, and 2 years). A chi-square test and Student t-test evaluated differences between the gender for demographic and operative variables where appropriate. Differences between the gender subgroup mean PHQ-9 scores were assessed using a t-test pre- and postoperatively (e.g., 6 weeks, 12 weeks, 6 months, and 1 year) and a paired t-test was used to assess differences from preoperative scores at each postoperative time point. Results: A total of 170 subjects underwent 125 ACDFs and 45 ADRs. Both pre- and postoperative timepoints demonstrated no significant differences between mean PHQ-9 scores by gender. Female patients demonstrated statistically significant improvement in PHQ-9 scores at 6 weeks, and 12 weeks, but not through 2 years. Male patients demonstrated statistically significant improvement in PHQ-9 scores at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years. Conclusion: Although there were no significant differences between mean PHQ-9 score between the genders, there was a difference in magnitude of improvement. Females had a significant improvement in depressive symptom severity over baseline at the 6- and 12-week timepoints only, whereas males had significant improvement through 2 years postoperatively.