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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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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)