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Junyoung Ahn, Daniel D. Bohl, Ehsan Tabaraee, Khaled Aboushaala, Islam M. Elboghdady and Kern Singh

OBJECT

Little is known about the accuracy of reporting of preoperative narcotic utilization in spinal surgery. As such, the purpose of this study is to compare postoperative narcotic consumption between preoperative narcotic utilizers who do and do not accurately self-report preoperative utilization.

METHODS

Patients who underwent anterior cervical discectomy and fusion, minimally invasive lumbar discectomy, or minimally invasive transforaminal lumbar interbody fusion procedures between 2013 and 2014 were prospectively identified. The accuracy of self-reporting preoperative narcotic consumption was determined utilizing the Illinois Prescription Monitoring Program. Total inpatient narcotic consumption during postoperative Days 0 and 1 was compared according to the demographics and preoperative narcotic reporting accuracy. Similarly, the proportion of patients who continued to be dependent on narcotic medications at each postoperative visit was compared according to the demographics and preoperative narcotic reporting accuracy.

RESULTS

A total of 195 patients met the inclusion criteria. Of these, 25% did not use narcotics preoperatively, while 47% and 28% did do so with accurate and inaccurate reporting, respectively. Patients who used narcotics preoperatively were more likely to demonstrate elevated inpatient narcotic consumption (adjusted RR 5.3; 95% CI 1.4–20.1; p = 0.013). However, such patients were no more or less likely to be dependent on narcotic medications at the first (p = 0.618) or second (p = 0.798) postoperative visit. Among patients who used narcotics preoperatively, no differences were demonstrated in terms of inpatient narcotic consumption (p = 0.182) or narcotic dependence following the first (p = 0.982) or second (p = 0.866) postoperative visit according to the self-reported accuracy of preoperative narcotic utilization. The only preoperative factors that were independently associated with elevated inpatient narcotic consumption were workers’ compensation status and procedure type. The only preoperative factors that were independently associated with narcotic dependence at the first postoperative visit were female sex, workers’ compensation status, and procedure type. The only preoperative factor that was independently associated with narcotic dependence at the second postoperative visit was procedure type.

CONCLUSIONS

The findings suggest that determining the actual preoperative narcotic utilization in patients who undergo spine surgery may help optimize postoperative pain management. Approximately 75% of patients used narcotics preoperatively. Patients who used narcotics preoperatively demonstrated significantly higher inpatient narcotic consumption, but this difference did not persist following discharge. Finally, postoperative narcotic consumption (inpatient and following discharge) was independent of the self-reported accuracy of preoperative narcotic utilization. Taken together, these findings suggest that corroboration between the patient’s self-reported preoperative narcotic utilization and other sources of information (e.g., family members and narcotic registries) may be clinically valuable with respect to minimizing narcotic requirements, thereby potentially improving the management of postoperative pain.

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Brittany E. Haws, Benjamin Khechen, Jordan A. Guntin, Kaitlyn L. Cardinal, Daniel D. Bohl and Kern Singh

OBJECTIVE

Patient-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.

METHODS

A 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.

RESULTS

Seventy-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.

CONCLUSIONS

Physical 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.

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Benjamin C. Mayo, Dustin H. Massel, Daniel D. Bohl, Ankur S. Narain, Fady Y. Hijji, William W. Long, Krishna D. Modi, Bryce A. Basques, Alem Yacob and Kern Singh

OBJECTIVE

Prior studies have correlated preoperative depression and poor mental health status with inferior patient-reported outcomes following lumbar spinal procedures. However, literature regarding the effect of mental health on outcomes following cervical spinal surgery is limited. As such, the purpose of this study is to test for the association of preoperative SF-12 Mental Component Summary (MCS) scores with improvements in Neck Disability Index (NDI), SF-12 Physical Component Summary (PCS), and neck and arm pain following anterior cervical discectomy and fusion (ACDF).

METHODS

A prospectively maintained surgical database of patients who underwent a primary 1- or 2-level ACDF during 2014–2015 was reviewed. Patients were excluded if they did not have complete patient-reported outcome data for the preoperative or 6-week, 12-week, or 6-month postoperative visits. At baseline, preoperative SF-12 MCS score was assessed for association with preoperative NDI, neck visual analog scale (VAS) score, arm VAS score, and SF-12 PCS score. The preoperative MCS score was then tested for association with changes in NDI, neck VAS, arm VAS, and SF-12 PCS scores from the preoperative visit to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics as well as for the preoperative score for the patient-reported outcome being assessed.

RESULTS

A total of 52 patients were included in the analysis. At baseline, a higher preoperative MCS score was negatively associated with a lower preoperative NDI (coefficient: −0.74, p < 0.001) and preoperative arm VAS score (−0.06, p = 0.026), but not preoperative neck VAS score (−0.03, p = 0.325) or SF-12 PCS score (0.04, p = 0.664). Additionally, there was no association between preoperative MCS score and improvement in NDI, neck VAS, arm VAS, or SF-12 PCS score at any of the postoperative time points (6 weeks, 12 weeks, and 6 months, p > 0.05 for each). The percentage of patients achieving a minimum clinically important difference at 6 months did not differ between the bottom and top MCS score halves (p > 0.05 for each).

CONCLUSIONS

The results of this study suggest that better preoperative mental health status is associated with lower perceived preoperative disability but is not associated with severity of preoperative neck or arm pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in patient-reported outcomes at any postoperative time point following an ACDF.

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Brittany E. Haws, Benjamin Khechen, Ankur S. Narain, Fady Y. Hijji, Daniel D. Bohl, Dustin H. Massel, Benjamin C. Mayo, Junyoung Ahn and Kern Singh

OBJECTIVE

Intraoperative 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.

METHODS

A 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.

RESULTS

Of 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).

CONCLUSIONS

The 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)

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Brittany E. Haws, Benjamin Khechen, Mundeep S. Bawa, Dil V. Patel, Harmeet S. Bawa, Daniel D. Bohl, Adam B. Wiggins, Kaitlyn L. Cardinal, Jordan A. Guntin and Kern Singh

OBJECTIVE

The 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.

METHODS

Studies 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.

RESULTS

Twenty-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.

CONCLUSIONS

There 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.

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Brittany E. Haws, Benjamin Khechen, Dil V. Patel, Mundeep S. Bawa, Junyoung Ahn, Daniel D. Bohl, Benjamin C. Mayo, Dustin H. Massel, Jordan A. Guntin, Kaitlyn L. Cardinal and Kern Singh

OBJECTIVE

Local epidural steroid application may be associated with decreased pain and narcotic use in the immediate postoperative period following lumbar discectomy. However, local steroid delivery following lumbar fusion procedures has not been well characterized. This study aims to characterize the effect of local intraoperative depomedrol application on perioperative and postoperative outcomes following a single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).

METHODS

A prospective, randomized, single-blinded study was performed. A priori power analysis determined that 86 patients were needed to detect a difference of 1 point in the visual analog scale (VAS) pain score between groups. Ninety-three patients were randomized into depomedrol (DEPO) and no depomedrol (NODEPO) cohorts. Prior to surgical closure, DEPO patients received 1 ml depomedrol (80 mg) applied directly to the surgical site by using a Gelfoam carrier. NODEPO patients received 1 ml saline on the same Gelfoam carrier. Perioperative outcomes including acute postoperative pain and narcotic use were assessed for the duration of inpatient stay. Patient-reported outcomes (PROs) questionnaires including VAS back and leg pain scores, and Oswestry Disability Index (ODI) were administered preoperatively and at 6-week, 12-week, and 6-month follow-up. Outcomes for DEPO and NODEPO cohorts were compared using linear regression controlled for sex.

RESULTS

Of the 93 patients, 45 (48.4%) were randomized to DEPO and 48 (51.6%) to NODEPO. A greater percentage of DEPO patients were female (53.3% vs 27.1%, p = 0.010). There were no other significant differences in patient baseline characteristics. Similarly, operating time, estimated blood loss, and length of inpatient stay did not differ between cohorts. Patients in the DEPO cohort consumed fewer hourly narcotics on postoperative day 0 (5.3 vs 6.3 oral morphine equivalents/hour, p = 0.034). However, no differences in acute postoperative pain or total narcotics consumption were observed between groups. Preoperative VAS leg scores were statistically different between cohorts (p = 0.027). However, preoperative ODI and VAS back scores did not differ between groups. Additionally, DEPO and NODEPO groups experienced similar improvements in PROs at all postoperative time points.

CONCLUSIONS

Local depomedrol use did not lead to decreases in acute postoperative pain or narcotics consumption after MIS TLIF. Additionally, local depomedrol was not associated with postoperative improvements in PROs. The findings of this randomized trial suggest that surgical and clinical outcomes following MIS TLIF may not be impacted by intraoperative application of depomedrol.

Clinical trial registration no.: NCT03308084 (clinicaltrials.gov)

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Brittany E. Haws, Benjamin Khechen, Dil V. Patel, Mundeep S. Bawa, Junyoung Ahn, Daniel D. Bohl, Benjamin C. Mayo, Dustin H. Massel, Jordan A. Guntin, Kaitlyn L. Cardinal and Kern Singh

OBJECTIVE

Local epidural steroid application may be associated with decreased pain and narcotic use in the immediate postoperative period following lumbar discectomy. However, local steroid delivery following lumbar fusion procedures has not been well characterized. This study aims to characterize the effect of local intraoperative depomedrol application on perioperative and postoperative outcomes following a single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).

METHODS

A prospective, randomized, single-blinded study was performed. A priori power analysis determined that 86 patients were needed to detect a difference of 1 point in the visual analog scale (VAS) pain score between groups. Ninety-three patients were randomized into depomedrol (DEPO) and no depomedrol (NODEPO) cohorts. Prior to surgical closure, DEPO patients received 1 ml depomedrol (80 mg) applied directly to the surgical site by using a Gelfoam carrier. NODEPO patients received 1 ml saline on the same Gelfoam carrier. Perioperative outcomes including acute postoperative pain and narcotic use were assessed for the duration of inpatient stay. Patient-reported outcomes (PROs) questionnaires including VAS back and leg pain scores, and Oswestry Disability Index (ODI) were administered preoperatively and at 6-week, 12-week, and 6-month follow-up. Outcomes for DEPO and NODEPO cohorts were compared using linear regression controlled for sex.

RESULTS

Of the 93 patients, 45 (48.4%) were randomized to DEPO and 48 (51.6%) to NODEPO. A greater percentage of DEPO patients were female (53.3% vs 27.1%, p = 0.010). There were no other significant differences in patient baseline characteristics. Similarly, operating time, estimated blood loss, and length of inpatient stay did not differ between cohorts. Patients in the DEPO cohort consumed fewer hourly narcotics on postoperative day 0 (5.3 vs 6.3 oral morphine equivalents/hour, p = 0.034). However, no differences in acute postoperative pain or total narcotics consumption were observed between groups. Preoperative VAS leg scores were statistically different between cohorts (p = 0.027). However, preoperative ODI and VAS back scores did not differ between groups. Additionally, DEPO and NODEPO groups experienced similar improvements in PROs at all postoperative time points.

CONCLUSIONS

Local depomedrol use did not lead to decreases in acute postoperative pain or narcotics consumption after MIS TLIF. Additionally, local depomedrol was not associated with postoperative improvements in PROs. The findings of this randomized trial suggest that surgical and clinical outcomes following MIS TLIF may not be impacted by intraoperative application of depomedrol.

Clinical trial registration no.: NCT03308084 (clinicaltrials.gov)