Study Design: This was a prospective cohort study. Objective: The objective of this study was to establish minimal clinically important difference (MCID) and substantial clinical benefit (SCB) thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) in cervical spine pathology. Summary of Background Data: PROMIS enables improved psychometric properties with reduced questionnaire burden through computer adaptive testing. Despite studies showing good correlation with “legacy” outcome measures, literature on the clinical significance of changes in PROMIS scores is scarce. Materials and Methods: Adult patients undergoing cervical spine surgery at a single institution between 2016 and 2018 were prospectively enrolled. Patients completed questionnaires [Short Form-36 (SF-36), Neck Disability Index (NDI), Visual Analogue Scale Arm/Neck, and PROMIS Pain Interference (PI) and Physical Function (PF)] preoperatively and at 6 months postoperatively. MCID was calculated using distribution-based and SCB using anchor-based methods. The SF-36 Health Transition Item was utilized as an anchor with the cutoff values chosen using receiver operating characteristic curve analysis. Results: There were 139 patients meeting inclusion criteria, with a mean age of 56.4 years and diagnoses of myelopathy (n=36), radiculopathy (n=48) and myeloradiculopathy (n=49). There were significant improvements in PROMIS PF, PROMIS PI, NDI, and SF-36 preoperatively to postoperatively (P<0.001). The test-retest reliability of all tests was excellent (intraclass correlation coefficients=0.87–0.94). PROMIS, SF-36, and NDI were all correlated with the anchor question (|r|=0.34–0.48, P<0.001). MCIDs were 8.5 (NDI), 11.1 (SF-36 Physical Component Score), 9.7 (SF-36 Mental Component Score), 4.9 (PROMIS PI), and 4.5 (PROMIS PF). SCB was 13.0 (NDI), 24.0 (SF-36 Physical Component Score), 11.8 (SF-36 Mental Component Score), 6.9 (PROMIS PI), and 6.8 (PROMIS PF). MCIDs were greater than standard error of measurement for all measures. Conclusions: We report MCID of 4.9 (PI) and 4.5 (PF) and SCB of 6.9 (PI) and 6.8 (PF). These data support the use of PROMIS computer adaptive tests in cervical spine patients and provide important reference as PROMIS reporting becomes more widespread in the literature.

OBJECTIVEThis study aimed to determine if the preoperative Patient-Reported Outcomes Measurement Information System, Physical Function (PROMIS PF) score is predictive of immediate postoperative patient pain and narcotics consumption or long-term patient-reported outcomes (PROs) following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).METHODSA prospectively maintained database was retrospectively reviewed. Patients who underwent primary, single-level MIS TLIF for degenerative pathology were identified and grouped by their preoperative PROMIS PF scores: mild disability (score 40–50), moderate disability (score 30–39.9), and severe disability (score 20–29.9). Postoperative pain was quantified using the visual analog scale (VAS), and narcotics consumption was quantified using Oral Morphine Equivalents. PROMIS PF, Oswestry Disability Index (ODI), 12-Item Short-Form Health Survey, Physical Component Summary (SF-12 PCS), and VAS back and leg pain were collected preoperatively and at 6-week, 3-month, 6-month, and 12-month follow-up. Preoperative PROMIS PF subgroups were tested for an association with demographic and perioperative characteristics using 1-way ANOVA or chi-square analysis. Preoperative PROMIS PF subgroups were tested for an association with immediate postoperative pain and narcotics consumption in addition to improvements in PROMIS PF, ODI, SF-12 PCS, and VAS back and leg pain by using linear regression controlling for statistically different demographic characteristics.RESULTSA total of 130 patients were included in this analysis. Patients were grouped by their preoperative PROMIS PF scores: 15.4% had mild disability, 63.8% had moderate disability, and 20.8% had severe disability. There were no significant differences among the subgroups in terms of age, sex, smoking status, and comorbidity burden. Patients with greater disability were more likely to be obese and to have workers’ compensation insurance. There were no differences among subgroups in regard to operative levels, operative time, estimated blood loss, and hospital length of stay. Patients with greater disability reported higher VAS pain scores and narcotics consumption for postoperative day 0 and postoperative day 1. Patients with greater preoperative disability demonstrated lower PROMIS PF, ODI, SF-12 PCS, and worse VAS pain scores at each postoperative time point.CONCLUSIONSPatients with worse preoperative disability, as assessed by PROMIS PF, experienced increased pain and narcotics consumption, along with less improvement in long-term PROs. The authors conclude that PROMIS PF is an efficient and accurate instrument that can quickly assess patient disability in the preoperative period and predict both short-term and long-term surgical outcomes.

OBJECTIVEIntraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF.METHODSA prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05.RESULTSOf the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation).CONCLUSIONSThe results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures.■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: Class I.Clinical trial registration no.: NCT03311425 (clinicaltrials.gov)

OBJECTIVEThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to provide a standardized measure of clinical outcomes that is valid and reliable across a variety of patient populations. PROMIS has exhibited strong correlations with many legacy patient-reported outcome (PRO) measures. However, it is unclear to what extent PROMIS has been used within the spine literature. In this context, the purpose of this systematic review was to provide a comprehensive overview of the PROMIS literature for spine-specific populations that can be used to inform clinicians and guide future work. Specifically, the authors aimed to 1) evaluate publication trends of PROMIS in the spine literature, 2) assess how studies have used PROMIS, and 3) determine the correlations of PROMIS domains with legacy PROs as reported for spine populations.METHODSStudies reporting PROMIS scores among spine populations were identified from PubMed/MEDLINE and a review of reference lists from obtained studies. Articles were excluded if they did not report original results, or if the study population was not evaluated or treated for spine-related complaints. Characteristics of each study and journal in which it was published were recorded. Correlation of PROMIS to legacy PROs was reported with 0.1 ≤ |r| < 0.3, 0.3 ≤ |r| < 0.5, and |r| ≥ 0.5 indicating weak, moderate, and strong correlations, respectively.RESULTSTwenty-one articles were included in this analysis. Twelve studies assessed the validity of PROMIS whereas 9 used PROMIS as an outcome measure. The first study discussing PROMIS in patients with spine disorders was published in 2012, whereas the majority were published in 2017. The most common PROMIS domain used was Pain Interference. Assessments of PROMIS validity were most frequently performed with the Neck Disability Index. PROMIS domains demonstrated moderate to strong correlations with the legacy PROs that were evaluated. Studies assessing the validity of PROMIS exhibited substantial variability in PROMIS domains and legacy PROs used for comparisons.CONCLUSIONSThere has been a recent increase in the use of PROMIS within the spine literature. However, only a minority of studies have incorporated PROMIS for its intended use as an outcomes measure. Overall, PROMIS has exhibited moderate to strong correlations with a majority of legacy PROs used in the spine literature. These results suggest that PROMIS can be effective in the assessment and tracking of PROs among spine populations.

Study Design. Retrospective review of prospectively collected data. Objective. To investigate if zero profile devices offer an advantage over traditional plate/cage constructs for dysphagia rates in single level anterior cervical discectomy and fusion (ACDF). Summary of Background Data. Dysphagia rates following ACDF have been reported to be as high as 83%, most cases are self-limiting, but chronic dysphagia can continue in up to 35% of patients. Zero profile devices were developed to limit dysphagia, and other plate specific complications, however the literature is currently divided regarding their efficacy. Methods. Dysphagia was assessed by swallowing quality of life (SWAL-QOL) scores preoperatively, at 6 weeks and 12 weeks. Patient reported outcome measures (PROMs) including visual analog scale (VAS) and Neck Disability Index (NDI) were collected preoperatively, at 6 weeks and at 6 months. Univariate and multivariate regression analysis was conducted with SWAL-QOL score as the dependent variable. Results. Sixty-four patients were included, 41 received a zero profile device, and 23 received plate-graft construct. Both groups were similar regarding patient demographics, except operative time, with the zero-profile group having a shorter procedure time than the cage-plate group (44.88 ± 6.54 vs. 54.43 ± 14.71 min, P = 0.001). At all timepoints dysphagia rates were similar between the groups. Regression analysis confirmed preoperative SWAL-QOL and operative time were the only significant variables. PROMs were also similar between groups at all time points, except VAS neck at 6 months, which was lower in the plate-graft group (1.05 ± 1.48 vs. 3.43 ± 3.21, P = 0.007). Conclusion. Operative time and preoperative SWAL-QOL scores are predictive of dysphagia in single level ACDF. Zero profile devices had a significantly shorter operative time, and may provide a benefit in dysphagia rates in this regard. Level of Evidence: 3

Study Design: This was a retrospective cohort study. Objective: This study evaluates if an association exists between preoperative depression and postoperative outcomes following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Summary of Background Data: Few studies have quantified preoperative depression symptoms using Patient Health Questionnaire-9 (PHQ-9) to predict postoperative outcomes after lumbar fusion, especially MIS TLIF. Methods: A surgical database of patients undergoing primary, single-level MIS TLIF was retrospectively reviewed. Patients were stratified by predefined preoperative PHQ-9 scores: no depression (<5), mild depression (5–9), and moderate to severe depression (≥10). Inpatient pain scores and narcotics use were recorded. Oswestry Disability Index, Veterans RAND-12 Mental Component Score and Physical Component Score, and Visual Analog Scale (VAS) back and leg pain scores were collected preoperatively and at 6-week, 12-week, and 6-month follow-up. One-way analysis of variance and χ2 analysis determined if an association existed between PHQ-9 subgroups and baseline characteristics or perioperative outcomes. Multivariate linear regression assessed for an association between PHQ-9 and postoperative patient-reported outcomes. Results: In total, 94 patients were included. Patients with higher PHQ-9 scores were younger, obese, and carried workers’ compensation insurance. Higher PHQ-9 scores were associated with worse preoperative Oswestry Disability Index, Veterans RAND-12 Mental Component Score and Physical Component Score, and VAS back and leg pain scores. Patients with higher PHQ-9 reported greater inpatient VAS pain scores on postoperative day 0 and 1 and demonstrated greater hourly narcotics consumption on postoperative day 0. Furthermore, higher PHQ-9 scores exhibited less improvement in all patient-reported outcomes. Conclusions: Patients with severe depression symptoms reported greater pain, increased narcotics consumption, and less clinical improvement after MIS TLIF. Therefore, patients with greater PHQ-9 scores should be monitored more closely and may benefit from additional counseling with regard to postoperative outcomes to better manage pain control and expectations of recovery.

Study Design: This study was a retrospective cohort analysis. Objectives: This study aims to evaluate the concurrent validity of Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) domain as compared with legacy measures of patient-reported outcomes (PROs) among patients undergoing anterior cervical discectomy and fusion (ACDF). Summary of Background Data: As PROMIS becomes increasingly utilized, it is important to assess its validity among procedure-specific populations. Methods: Patients undergoing a primary, 1–3 level ACDF were retrospectively identified from a prospectively maintained surgical registry. PROMIS PF and legacy PRO scores were obtained at preoperative, 6-week, 12-week, and 6-month postoperative visits. Legacy PROs included Neck Disability Index (NDI), Short Form-12 (SF-12) physical composite, Visual Analog Scale (VAS) neck pain, and VAS arm pain. Postoperative improvements in PROs were assessed using paired t tests. Correlations between PROMIS and legacy PROs were tested using Pearson correlation coefficient. Results: A total of 57 ACDF patients were analyzed. The mean preoperative PROMIS PF was 40.0±6.4. PROMIS PF significantly improved at 12-week and 6-month follow-up. NDI, VAS neck pain, and VAS arm pain scores demonstrated significant improvement at all postoperative time points. SF-12 scores only exhibited significant improvement at the 6-month follow-up visit. Significant correlations between PROMIS PF, NDI, and SF-12 were identified at all preoperative and postoperative time points. PROMIS PF exhibited strong correlations with VAS neck pain at postoperative time points, and a moderate correlation preoperatively. Conclusions: Patients undergoing a primary 1–3 level ACDF experience significant improvements in PROMIS PF scores at 12-week and 6-month follow-up. Furthermore, PROMIS PF exhibits strong correlations to NDI and SF-12 at all preoperative and postoperative time points. These results suggest that PROMIS PF accurately measures PF and may be used in lieu of legacy PF instruments for patients undergoing ACDF.

OBJECTIVEPatient-reported outcomes are commonly used to evaluate treatment efficacy. Inefficiencies in standard measurement tools often prove to be a barrier to data collection. The Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to overcome these limitations. This tool implements computer-adaptive testing, which enables the assessment of physical function in fewer questions than those required for “static” metrics. In spine surgery patients, moderate to strong correlations with Oswestry Disability Index (ODI) and the 36-Item Short Form Survey (SF-36) scores have been reported for PROMIS. However, to date, data regarding the efficacy of this tool for patients undergoing minimally invasive (MIS) transforaminal lumbar interbody fusion (TLIF) have been limited.METHODSA prospectively maintained registry of patients who have undergone primary 1- or 2-level MIS TLIF was reviewed retrospectively. Patients with incomplete PROMIS data were excluded. Changes in PROMIS physical function scores 6 weeks, 12 weeks, and 6 months after surgery were analyzed using paired t-tests. PROMIS scores were compared with traditional outcome measures, including SF-12 physical function, ODI, and visual analog scale (VAS) back and leg scores. Correlations were tested using the Pearson correlation coefficient, and the strength of association was interpreted as follows: small, 0.1 ≤ |r| < 0.3; moderate, 0.3 ≤ |r| < 0.5; and large, |r| ≥ 0.5. Statistical significance was set at p < 0.05.RESULTSSeventy-four patients were included in this analysis after the exclusion of those without PROMIS scores. The mean preoperative PROMIS score was 35.92 ± 6.98. Significant improvements were demonstrated in PROMIS scores 12 weeks (41.33, p < 0.001) and 6 months (43.58, p < 0.001) after surgery. PROMIS scores demonstrated a significant correlation with SF-12, ODI, and VAS leg scores (p < 0.05). Strong associations with PROMIS scores were observed for SF-12 (r = 0.650 to 0.854), ODI (r = −0.525 to −0.831), and 6-month VAS back (r = −0.693) scores.CONCLUSIONSPhysical function as measured by PROMIS improves significantly 12 weeks and 6 months after MIS TLIF. In addition, PROMIS scores have strong correlations with SF-12 and ODI scores. These results suggest that PROMIS scores can be used as a valid assessment of physical function in MIS TLIF patients. Further work is required to determine the full benefits of this measure in other spine populations.