Health-related quality of life measures in adult spinal deformity: can we replace the SRS-22 with PROMIS?

PURPOSE: To determine the validity and responsiveness of PROMIS metrics versus the SRS-22r questionnaire in adult spinal deformity (ASD). METHODS: Surgical ASD patients undergoing ≥ 4 levels fused with complete baseline PROMIS and SRS-22r data were included. Internal consistency (Cronbach's alpha) and test-retest reliability [intraclass correlation coefficient (ICC)] were compared. Cronbach's alpha and ICC values ≥ 0.70 were predefined as satisfactory. Convergent validity was evaluated via Spearman's correlations. Responsiveness was assessed via paired samples t tests with Cohen's d to assess measure of effect (baseline to 3 months). RESULTS: One hundred and ten pts are included. Mean baseline SRS-22r score was 2.62 ± 0.67 (domains = Function: 2.6, Pain: 2.5, Self-image: 2.2, Mental Health: 3.0). Mean PROMIS domains = Physical Function (PF): 12.4, Pain Intensity (PI): 91.7, Pain Interference (Int): 55.9. Cronbach's alpha, and ICC were not satisfactory for any SRS-22 and PROMIS domains. PROMIS-Int reliability was low for all SRS-22 domains (0.037-0.225). Convergent validity demonstrated strong correlation via Spearman's rho between PROMIS-PI and overall SRS-22r (- 0.61), SRS-22 Function (- 0.781), and SRS-22 Pain (- 0.735). PROMIS-PF had strong correlation with SRS-22 Function (0.643), while PROMIS-Int had moderate correlation with SRS-22 Pain (- 0.507). Effect size via Cohen's d showed that PROMIS had superior responsiveness across all domains except for self-image. CONCLUSIONS: PROMIS is a valid measure compared to SRS-22r in terms of convergent validity, and has greater measure of effect in terms of responsiveness, but failed in reliability and internal consistency. Surgeons should consider the lack of reliability and internal consistency (despite validity and responsiveness) of the PROMIS to SRS-22r before replacing the traditional questionnaire with the computer-adaptive testing.

Cannabinoids in treatment-resistant epilepsy: A review.

Treatment-resistant epilepsy (TRE) affects 30% of epilepsy patients and is associated with severe morbidity and increased mortality. Cannabis-based therapies have been used to treat epilepsy for millennia, but only in the last few years have we begun to collect data from adequately powered placebo-controlled, randomized trials (RCTs) with cannabidiol (CBD), a cannabis derivative. Previously, information was limited to case reports, small series, and surveys reporting on the use of CBD and diverse medical marijuana (MMJ) preparations containing: tetrahydrocannabinol (THC), CBD, and many other cannabinoids in differing combinations. These RCTs have studied the safety and explored the potential efficacy of CBD use in children with Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). The role of the placebo response is of paramount importance in studying medical cannabis products given the intense social and traditional media attention, as well as the strong beliefs held by many parents and patients that a natural product is safer and more effective than FDA-approved pharmaceutical agents. We lack valid data on the safety, efficacy, and dosing of artisanal preparations available from dispensaries in the 25 states and District of Columbia with MMJ programs and online sources of CBD and other cannabinoids. On the other hand, open-label studies with 100mg/ml CBD (Epidiolex®, GW Pharmaceuticals) have provided additional evidence of its efficacy along with an adequate safety profile (including certain drug interactions) in children and young adults with a spectrum of TREs. Further, Phase 3 RCTs with Epidiolex support efficacy and adequate safety profiles for children with DS and LGS at doses of 10- and 20-mg/kg/day. This article is part of a Special Issue titled "Cannabinoids and Epilepsy".

The Impact of Social Determinants of Health on Discharge Disposition Following One- and Two-Level Posterior Interbody Fusion.

Background Current research is limited in exploring the impact of social determinants of health (SDOH) on the discharge location within elective spine surgery. Further understanding of the influence of SDOH on disposition is necessary to improve outcomes. This study explores how SDOH influence discharge disposition for patients undergoing one- or two-level posterior interbody fusion (TLIF/PLIF). Methods This was a retrospective propensity-matched cohort study. Patients who underwent TLIF/PLIF between 2017 and 2020 at a single academic medical center were identified. The chart review gathered demographics, perioperative characteristics, intra/post-operative complications, discharge disposition, and 90-day outcomes. Discharge dispositions included subacute nursing facility (SNF), home with self-care (HSC), home with health services (HHS), and acute rehab facility (ARF). Demographic, perioperative, and disposition outcomes were analyzed by chi-square analysis and one-way ANOVA based on gender, race, and income quartiles. Results Propensity score matching for significant demographic factors isolated 326 patients. The rate of discharge to SNF was higher in females compared to males (25.00% vs 10.56%; p=0.001). Men were discharged to home at a higher rate than women (75.4% vs 61.95%; p=0.010). LatinX patients had the highest rate of home discharge, followed by Asians, Caucasians, and African Americans (83.33% vs 70.31% vs 66.45% vs 65.90%; p<0.001). The post hoc Tukey test demonstrated statistically significant differences between Asians and all other races in the context of age and BMI. Additionally, patients discharged to SNF showed the highest Charlson comorbidity index (CCI) score, followed by those at ARF, HHS, and HSC (4.36 vs 4.05 vs 2.87 vs 2.37; p<0.001). The estimated median income for the cohort ranged from $52,000 to $250,001, with no significant differences in income seen across comparisons. Conclusion Discharge disposition following one- or two-level TLIF/PLIF shows significant association with gender and race. No association was seen when comparing discharge rates among zip code-level median income quartiles.

A predictive model of perioperative myocardial infarction following elective spine surgery.

Myocardial infarction (MI), and its predictive factors, has been an understudied complication following spine operations. The objective was to assess the risk factors for perioperative MI in elective spine surgery patients as a retrospective case control study. Elective spine surgery patients with a perioperative MI were isolated in the NSQIP. The relationship between MI and non-MI spine patients was assessed using chi-squared and independent samples t-tests. Univariate/multivariate analyses assessed predictive factors of MI. Logistic regression with stepwise model selection was employed to create a model to predict MI occurrence. The study included 196,523 elective spine surgery patients (57.1 yrs, 48%F, 30.4 kg/m2), and 436 patients with acute MI (Spine-MI). Incidence of MI did not change from 2010 to 2016 (0.2%-0.3%, p = 0.298). Spine-MI patients underwent more fusions than patients without MI (73.6% vs 58.4%, p < 0.001), with an average of 1.03 levels fused. Spine-MI patients also had significantly more SPO (5.0% vs 1.8%, p < 0.001) and 3CO (0.9% vs 0.2%, p < 0.001), but less decompression-only procedures (26.4% vs 41.6%, p < 0.001). Spine-MI underwent more revisions (5.3% vs 2.9%, p = 0.003), had greater invasiveness scores (3.41 vs 2.73, p < 0.001) and longer operative times (211.6 vs 147.3 min, p < 0.001). Mortality rate for Spine-MI patients was 4.6% versus 0.05% (p < 0.001). Multivariate modeling for Spine-MI predictors yielded an AUC of 83.7%, and included history of diabetes, cardiac arrest and PVD, past blood transfusion, dialysis-dependence, low preoperative platelet count, superficial SSI and days from operation to discharge. A model with good predictive capacity for MI after spine surgery now exists and can aid in risk-stratification of patients, consequently improving preoperative patient counseling and optimization in the peri-operative period.

Establishing the minimal clinically important difference for the PROMIS Physical domains in cervical deformity patients.

INTRODUCTION: Patient Reported Outcome Measurement Information System (PROMIS) instruments have been shown to correlate with established patient outcome metrics. The aim of this retrospective study was to determine the MCID for the PROMIS physical domains of Physical Function (PF), Pain Intensity (PI), and Pain Interference (Int) in a population of surgical cervical deformity (CD) patients. METHODS: Surgical CD patients ≥ 18 years old with baseline (BL) and 3-month (3 M) HRQL data were isolated. Changes in HRQLs: ΔBL-3M. An anchor-based methodology was used. The cohort was divided into four groups: 'worse' (ΔEQ5D ≤ -0.12), 'unchanged' (≥0.12, but < -0.12), 'slightly improve' (>0.12, but ≤ 0.24), and 'markedly improved' (>0.24) [0.24 is the MCID for EQ5D]. PROMIS-PF, PI and Int at 3M was compared between 'slightly improved' and 'unchanged'. ROC computed discrete MCID values using the change in PROMIS that yielded the smallest difference between sensitivity ('slightly improved') and specificity ('unchanged'). We repeated anchor-based methods for the Ames-ISSG classification of severe deformity. RESULTS: 140 patients were included. EQ5D groups: 9 patients 'worse', 53 'unchanged', 20 'slightly improved', and 57 'markedly improved'. Patients classified as 'unchanged' exhibited a PROMIS-PF improvement of 2.9 ± 17.0 and those 'slightly improved' had an average gain of 13.3 ± 17.8. ROC analysis for the PROMIS-PF demonstrated an MCID of +2.26, for PROMIS-PI of -5.5, and PROMIS-Int of -5.4. In the Ames-ISSG TS-CL severe CD modifier, ROC analysis found MCIDs of PROMIS physical domains: PF of +0.5, PI of -5.2, and Int of -5.4. CONCLUSIONS: MCID for PROMIS physical domains were established for a cervical deformity population. MCID in PROMIS Physical Function was significantly lower for patients with severe cervical deformity.

COVID-19 pandemic and elective spinal surgery cancelations - what happens to the patients?

BACKGROUND CONTEXT: The COVID-19 pandemic caused nationwide suspensions of elective surgeries due to reallocation of resources to the care of COVID-19 patients. Following resumption of elective cases, a significant proportion of patients continued to delay surgery, with many yet to reschedule, potentially prolonging their pain and impairment of function and causing detrimental long-term effects. PURPOSE: The aim of this study was to examine differences between patients who have and have not rescheduled their spine surgery procedures originally cancelled due to the COVID-19 pandemic, and to evaluate the reasons for continued deferment of spine surgeries even after the lifting of the mandated suspension of elective surgeries. STUDY DESIGN/SETTING: Retrospective case series at a single institution PATIENT SAMPLE: Included were 133 patients seen at a single institution where spine surgery was canceled due to a state-mandated suspension of elective surgeries from March to June, 2020. OUTCOME MEASURES: The measures assessed included preoperative diagnoses and neurological dysfunction, surgical characteristics, reasons for surgery deferment, and PROMIS scores of pain intensity, pain interference, and physical function. METHODS: Patient electronic medical records were reviewed. Patients who had not rescheduled their canceled surgery as of January 31, 2021, and did not have a reason noted in their charts were called to determine the reason for continued surgery deferment. Patients were divided into three groups: early rescheduled (ER), late rescheduled (LR), and not rescheduled (NR). ER patients had a date of surgery (DOS) prior to the city's Phase 4 reopening on July 20, 2020; LR patients had a DOS on or after that date. Statistical analysis of the group findings included analysis of variance with Tukey's honestly significant difference (HSD) post-hoc test, independent samples T-test, and chi-square analysis with significance set at p≤.05. RESULTS: Out of 133 patients, 47.4% (63) were in the ER, 15.8% (21) in the LR, and 36.8% (49) in the NR groups. Demographics and baseline PROMIS scores were similar between groups. LR had more levels fused (3.6) than ER (1.6), p= .018 on Tukey HSD. NR (2.1) did not have different mean levels fused than LR or ER, both p= >.05 on Tukey HSD. LR had more three column osteotomies (14.3%) than ER and (1.6%) and NR (2.0%) p=.022, and fewer lumbar microdiscectomies (0%) compared to ER (20.6%) and NR (10.2%), p=.039. Other surgical characteristics were similar between groups. LR had a longer length of stay than ER (4.2 vs 2.4, p=.036). No patients in ER or LR had a nosocomial COVID-19 infection. Of NR, 2.0% have a future surgery date scheduled and 8.2% (4) are acquiring updated exams before rescheduling. 40.8% (20; 15.0% total cohort) continue to defer surgery over concern for COVID-19 exposure and 16.3% (8) for medical comorbidities. 6.1% (3) permanently canceled for symptom improvement. 8.2% (4) had follow-up recommendations for non-surgical management. 4.1% (2) are since deceased. CONCLUSION: Over 1/3 of elective spine surgeries canceled due to COVID-19 have not been performed in the 8 months from when elective surgeries resumed in our institution to the end of the study. ER patients had less complex surgeries planned than LR. NR patients continue to defer surgery primarily over concern for COVID-19 exposure. The toll on the health of these patients as a result of the delay in treatment and on their lives due to their inability to return to normal function remains to be seen.