Development of prediction models for clinically meaningful improvement in PROMIS scores after lumbar decompression

BACKGROUNDThe ability to preoperatively predict which patients will achieve a minimal clinically important difference (MCID) after lumbar spine decompression surgery can help determine the appropriateness and timing of surgery. Patient-Reported Outcome Measurement Information System (PROMIS) scores are an increasingly popular outcome instrument.PURPOSEThe purpose of this study was to develop algorithms predictive of achieving MCID after primary lumbar decompression surgery.PATIENT SAMPLEThis was a retrospective study at two academic medical centers and three community medical centers including adult patients 18 years or older undergoing one or two level posterior decompression for lumbar disc herniation or lumbar spinal stenosis between January 1, 2016 and April 1, 2019.OUTCOME MEASURESThe primary outcome, MCID, was defined using distribution-based methods as one half the standard deviation of postoperative patient-reported outcomes (PROMIS physical function, pain interference, pain intensity).METHODSFive machine learning algorithms were developed to predict MCID on these surveys and assessed by discrimination, calibration, Brier score, and decision curve analysis. The final model was incorporated into an open access digital application.RESULTSOverall, 906 patients completed at least one PROMs survey in the 90 days before surgery and at least one PROMs survey in the year after surgery. Attainment of MCID during the study period by PROMIS instrument was 74.3% for physical function, 75.8% for pain interference, and 79.2% for pain intensity. Factors identified for preoperative prediction of MCID attainment on these outcomes included preoperative PROs, percent unemployment in neighborhood of residence, comorbidities, body mass index, private insurance, preoperative opioid use, surgery for disc herniation, and federal poverty level in neighborhood of residence. The discrimination (c-statistic) of the final algorithms for these outcomes was 0.79 for physical function, 0.74 for pain interference, and 0.69 for pain intensity with good calibration. The open access digital application for these algorithms can be found here: https://sorg-apps.shinyapps.io/promis_pld_mcid/CONCLUSIONLower preoperative PROMIS scores, fewer comorbidities, and certain sociodemographic factors increase the likelihood of achieving MCID for PROMIS after lumbar spine decompression.     

Early Experience and Results Using Patient-Reported Outcomes Measurement Information System Scores in Primary Total Hip and Knee Arthroplasty

BackgroundOur study determined if preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores could predict achieving minimum clinically important differences (MCIDs) in postoperative PROMIS scores after primary total hip and knee arthroplasty.MethodsNinety-three patients were administered the PROMIS Depression, Pain Interference, and Physical Function domains at their preoperative appointment and 6-week follow-up visit. MCIDs were drawn from existing literature for the PROMIS domains.ResultsThe MCID was achieved in 74% of patients for Pain Interference, 34% for Physical Function, and 24% for Depression. Our model could predict with 90% specificity which patients would meet MCID if their preop PROMIS Pain score was above 38, Physical Function score less than 19, or Depression score above 22.ConclusionPreoperative PROMIS Pain Interference, Physical Function, and Depression scores can predict achieving MCID in postoperative PROMIS scores.     

Role of preoperative PROMIS scores in predicting postoperative outcomes and likelihood of achieving MCID following reverse shoulder arthroplasty

BackgroundThe patient-reported outcomes measurement information system (PROMIS) has emerged as an efficient and valid outcome measure in various shoulder surgeries. The purpose of this study was to investigate the influence of preoperative PROMIS scores in predicting postoperative PROMIS scores and the likelihood of achieving a minimal clinically important difference (MCID) following primary reverse total shoulder arthroplasty for cuff tear arthropathy. We hypothesize that preoperative PROMIS scores will influence both postoperative PROMIS scores and the probability of achieving MCID.Methods73 patients undergoing reverse shoulder arthroplasty by a board-certified shoulder and elbow surgeon were given three PROMIS CAT forms: PROMIS Upper Extremity Physical Function CAT v2.0 (“PROMIS-UE”), PROMIS Pain Interference v1.1 (“PROMIS-PI”), and PROMIS Depression v1.0 (“PROMIS-D”).). PROMIS CAT domain t scores were assessed for significance between both time points using a Paired Samples t test. Minimal clinically important difference (MCID) was calculated using the distribution method and each PROMIS domain was subsequently assessed for its discriminatory ability in predicting postoperative improvement equal to or greater than the MCID through receiver operating characteristic (ROC) curve analysis.ResultsOur cohort consisted of 73 patients (49.3% male) and an average age of 69.7 years (standard deviation, 11.9). Mean follow-up time point was 9.6 months (standard deviation, 5.0) after surgery. Preoperative PROMIS-UE, PROMIS-PI, and PROMIS-D were 29.5 ± 6.2, 63.3 ± 5.4, and 50.1 ± 9.2, respectively. Each domain significantly improved at 10-months, on average, to 40.9 ± 7.8, 51.4 ± 8.5, 42.6 ± 8.1, respectively. Following the distribution-based method for MCID calculation, we found the following MCID values for PROMIS-UE, PROMIS-PI, and PROMIS-D: 3.1, 2.7, and 4.6, respectively. ROC analysis revealed strong predictive ability for PROMIS-UE (AUC = 0.717, p < 0.05), moderative predictive ability for PROMIS-PI (AUC = 0.634, p < 0.05), and excellent predictive ability for PROMIS-D (AUC = 0.864, p < 0.05). Specifically, preoperative cutoff values of <26.0, >70.0, and >52.5 for PROMIS-UE, PROMIS-PI, and PROMIS-D are especially predictive of achieving MCID.ConclusionsPreoperative baseline scores can serve as strong predictors of success in patients undergoing primary reverse shoulder arthroplasty and can be used to both counsel patients on surgery and to tailor postoperative protocols.Level of evidenceLevel II.     

The effect of smoking on achieving meaningful clinical outcomes one year after lumbar tubular microdecompression: a matched-pair cohort analysis

BACKGROUND CONTEXTThere has been a shift in the spine literature in reporting meaningful outcomes, including meaningful clinically important difference (MCID), after surgery. The evidence on the effect of tobacco smoking at the time of lumbar tubular microdecompression (LTMD) on meaningful outcomes is limited.PURPOSETo compare differences in 1-year functional outcomes and rates of achieving MCID between current smokers and non-smokers who underwent LTMD for lumbar spinal stenosis (LSS).STUDY DESIGNA nested case control study to compare the difference in patient reported outcomes (PROs) between smokers and non-smokers 1-year after undergoing LTMD.PATIENT SAMPLEThis study included patients that underwent single level LTMD by a single surgeon between January 2014 through August 2019.OUTCOME MEASURESPreoperative and postoperative PROs were recorded using the questionnaires EQ-5D, Oswestry Disability Index (ODI), and the visual analog scale (VAS) for back pain and leg pain. The MCID was also used.METHODSCurrent tobacco smokers at the time of surgery were matched 1:2 to non-smokers by age (+/- 1year). Preoperative and postoperative functional scores were compared between the two groups using independent t-tests. Additionally, thresholds for achieving MCID were calculated for each individual functional score, and were compared using Fisher's exact test.RESULTSOf the 183 patients with 1-year follow-up who met inclusion criteria, 35 patients were identified as smokers and were matched to 70 non-smokers. No statistical differences were identified between age, BMI, or gender. Comparison of preoperative PROs showed no statistically significant differences between smokers and non-smokers (p>0.05 for all), while smokers had statistically lower EQ-5D (p<0.001) and higher ODI (p=0.05), VAS back (p=0.033), and VAS leg (p=0.03) score averages at a minimum of one year follow-up. Evaluation of meaningful outcomes demonstrated non-smokers had higher rates of achieving MCID on at least 1 threshold score as compared to smokers (98.5% vs. 91.1%; p=0.043).CONCLUSIONSCurrent smokers at the time of surgery have inferior postoperative EQ-5D scores, increased pain and disability, and lower odds of achieving the MCID at 1-year after undergoing LTMD when compared to patients without any smoking history.     

The Impact of Total Hip Arthroplasty Surgical Approach on Patient-Reported Outcomes Measurement Information System Computer Adaptive Tests of Physical Function and Pain Interference

BackgroundThe present study examines Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Test (CAT) scores for domains of physical function (PF) and pain interference (PI) in patients undergoing elective THA from either a direct anterior or posterior surgical approach.MethodsA total of 1358 patients who underwent THA at our institution from 1/1/2015 to 12/1/2018 were identified. Visual analog scale (VAS) pain scores, PROMIS CAT PF and PI data were collected at the last preoperative visit as well as 6 weeks, 6 months, and 1-2 years postoperatively. Literature-derived minimum clinically important difference (MCID) for PROMIS CAT PF metric with regard to THA was used for data comparison.ResultsFour hundred nine patients were included in the final analysis. Fifty-one percent underwent a posterior approach, and 49% underwent a direct anterior approach. Both approaches led to a significant improvement in PROMIS CAT PF and PI scores. Patients undergoing a direct anterior approach had significantly higher preoperative and postoperative PROMIS CAT PF scores as well as significantly lower preoperative PROMIS CAT PI scores. Each approach yielded similar interval improvements of PROMIS CAT PF and PI. One hundred three direct anterior approach THA patients (51%) and 119 posterior approach THA patients (57.5%) achieved PROMIS PF MCID at 1- to 2-year follow-up.ConclusionNeither the direct anterior nor posterior THA surgical approach conferred an advantage to postoperative improvements of PROMIS CAT PF and PI scores. Adult reconstructive surgeons should continue to execute the direct anterior or posterior THA surgical approaches based upon personal preference. Despite surgeon confidence in THA, the potential for further innovation exists given the number of THA patients who failed to achieve PROMIS PF MCID.     

Minimal clinically important difference in patients who underwent decompression alone for lumbar degenerative disease

Background ContextThe minimal clinically important difference (MCID) represents the smallest change in an outcome measure recognized as clinically meaningful to a patient after receiving a clinical intervention. Most studies that discussed the MCIDs for lumbar spinal stenosis (LSS) included mixed pathologies or procedures despite that the MCID value should be different depending on the intervention. Moreover, despite the efficacy of adopting percentage-change improvement for the MCID threshold, there are limited reports and discussions in the field of lumbar surgery.PurposeThe aim of the present study was to elucidate the MCIDs for the Oswestry Disability Index (ODI), EuroQOL 5-dimension 3-level (EQ-5D-3L), physical component summary (PCS) of the Short Form of the Medical Outcomes Study, and Numeric Rating Scale (NRS) in patients with degenerative LSS treated with decompression surgery without fusion.Study Design/SettingA multicenter retrospective cohort study was performed.Patient SampleA total of 422 patients who underwent decompression surgery for LSS and answered a complete set of questionnaires were included in the study. Patients who underwent endoscopic or revision surgery were excluded.Outcome MeasuresPreoperative and 1-year postoperative scores of each health-related quality of life questionnaires (HRQOLs) and patient satisfaction questionnaire responseMethodsThe patient satisfaction question was used as an anchor, and the cutoff values were estimated based on absolute point improvement from baseline using a receiver-operating characteristic (ROC) curve analysis and the “mean change” method for MCIDs. The MCID values for percentage-change in HRQOLs were also calculated using ROC curve analysis. The three cutoff values for each HRQOL were validated using the Youden index for determining the most robust MCIDs.ResultsOf the patients, 356 (84.4%) were at least “somewhat satisfied” with the treatment results. The two cutoff values of absolute point-change in each HRQOL, which were estimated by two different anchor-based methods, were similar. The area under the curve of the ROC curve for percentage-change tended to be higher than that for absolute point-change. Moreover, the Youden index of the percentage-change in each HRQOL was higher than that of the absolute point-change calculated by either the “mean change” method or the ROC curve analysis. Based on these results, it was proposed that MCID was 42.4% for percentage-change in ODI, 22.0% for EQ-5D-3L, 13.7% for PCS, 25.0% for NRS (low back pain), 55.6% for NRS (leg pain), 22.2% for NRS (leg numbness).ConclusionsThe MCIDs of HRQOLs were calculated in patients with LSS treated with decompression surgery without concomitant fusion procedure. The MCID cutoffs based on percentage-change from baseline were more effective than those of absolute point-change.     

How does preoperative opioid use impact postoperative health-related quality of life scores for patients undergoing lumbar microdiscectomy?

Background ContextNarcotic use amongst patients suffering from lumbar radiculopathy is common, but the clinical benefit of narcotics for lumbar radiculopathy is likely minimal. It is unknown what the impact of preoperative use of narcotics has on outcomes related to lumbar microdiscectomy.PurposeDetermine the impact that preoperative opioid use has on postoperative outcomes after lumbar microdisectomy.Study DesignRetrospective analysis of a prospectively collected database.Patient SampleOne hundred and twenty-six patients undergoing a microdiscectomy for a lumbar disc herniation.Outcome MeasuresPatient-reported outcomes measurement information system mental health scores (PROMIS MHS), patient-reported outcomes measurement information system physical health scores (PROMIS PHS) and oswestry disability index (ODI).MethodsWe analyzed a prospectively collected database of patients undergoing a lumbar microdiscectomy for preoperative opioid use. We measured the severity of lumbar pathology on MRI based on degree of facet/disc degeneration and cross-sectional area of the dural tube at the disc herniation. We tracked PROMIS MHS, PROMIS PHS and ODI for patients both preoperatively and postoperatively. A Mann-Whitney test was used to compare HRQOL scores and time to MCID for the opioid using cohort (OC) and the nonopioid using cohort (non-OC). We performed a linear regression analysis to determine correlation between preoperative opioid use and postoperative HRQOLs.ResultsThere were 44 of 126 microdiscectomy patients in the OC (32.5%). There was no difference in the dural cross-sectional area (p=.91), degree of facet degeneration (p=.38), or disc degeneration (p=.5) between OC and non-OC. There were no differences in PROMIS PHS, PROMIS MHS or ODI between the OC and non-OC at the preoperative visit and all postoperative time points. There were no differences in time to reach MCID between the OC and non-OC for ODI (p=.9), PROMIS PHS (p=.64) or PROMIS MHS (p=.90). At three months out from surgery there was a statistically significant correlation between pre-op opioid use and ODI (p=.02), PROMIS MHS (p=.02) and PROMIS PHS (p=.049).ConclusionsOur results demonstrate that patients that use opioids prior to lumbar microdiscectomy have equivalent postoperative outcomes as those that do not use opioids. Use of higher doses of opioids is associated with worse short-term outcomes.     

Evaluation of transforaminal epidural steroid injections for discogenic axial lumbosacral back pain utilizing PROMIS as an outcome measure

Background contextDiscogenic lumbosacral back pain continues to present a challenging clinical entity with limited, controversial therapeutic options. No study to date has evaluated the efficacy of fluoroscopically guided transforaminal epidural steroid injections (TFESI) in a homogenous patient population with axial lumbosacral back pain from discogenic pathology utilizing strict, explicitly clinical and radiographic criteria. Additionally, there is a paucity of published data utilizing Patient Reported Outcome Measurement Information System (PROMIS) scores as an outcome measure for interventional spine procedures.PurposeEvaluate the therapeutic effect of TFESIs in a specific subset of patients with discogenic axial lumbosacral back pain. Investigate PROMIS as an outcome measure for interventional spine procedures targeting focal degenerative spinal pathology.Study design/settingRetrospective review of patients presenting to a multidisciplinary, tertiary academic spine center.Patient sampleThree thousand eight hundred eighty-one patients were screened for inclusion. A total of 26 patients with discogenic axial low back, based on strict clinical and radiographic criteria, underwent TFESIs. All patients had axial low back pain without radicular pain, ≥3 clinical features of discogenic pain, corroborative radiographic features of active discogenic pathology on lumbar spine magnetic resonance imaging without confounding spinal pathology.Outcome measuresPROMIS Pain Interference (PI) v1.1, PROMIS Physical Function (PF) v1.2/v2.0, and PROMIS Depression (D) v1.0 outcome scores were collected at baseline and postprocedure follow-up.MethodsQuery of an institutional, patient reported outcome database and subsequent retrospective review of electronic medical records was performed. Statistical analysis comparing baseline and postprocedural PROMIS outcome scores and correlation between these instruments was performed. Additionally, an exploratory investigation of minimal clinically important difference achievement rates was performed.ResultsAnalysis determined a statistically significant improvement in PROMIS PI (p=.017, 95% CI=?8.02 to ?1.82) and PROMIS PF (p=.003, 95% CI=0.91–8.72) scores after treatment with TFESIs. At post treatment time points, TFESI had medium effect size on pain (d=0.55) and function (d=0.59). Change in PROMIS D scores (p=.488, 95% CI ?1.74–3.54; d=.08) did not demonstrate statistical significance. Pearson correlation demonstrated a moderate negative correlation (r=?0.544, p=.004) between PROMIS PF with PROMIS PI. Correlation between PROMIS PF (r=?0.239, p=.24) and PROMIS PI (r=0.198, p=.33) with PROMIS D was not significant. Fourteen (53.8%) and 9 (34.6%) subjects achieved minimum clinically important difference (MCID) for PROMIS PI and PROMIS PF, respectively. Nine subjects (34.6%) achieved MCID for PROMIS D despite not otherwise reaching statistical significance otherwise.ConclusionsUtilizing PROMIS as an outcome measure, discogenic axial lumbosacral back pain patients appear to benefit from TFESI in terms of pain and physical function. This study contributes to the growing body of literature utilizing PROMIS scores in patients with clinical sequelae of degenerative spinal pathology; however, prospective studies are needed.     

The influence of gender on postoperative PROMIS physical function outcomes following minimally invasive transforaminal lumbar interbody fusion

PurposeOur aim is to examine the gender performance of Patient-Reported Outcome Measurement Information System Physical Function (PROMIS-PF) scores among patients undergoing minimally invasive transforaminal lumbar fusion (MIS TLIF).MethodsA prospectively collected surgical dataset was retrospectively assessed for eligible patients from March 2015–June 2019. We included patients if they underwent primary MIS TLIF procedures on one or two vertebral levels. We collected baseline demographics, perioperative characteristics, and PROMIS-PF scores for each subject at pre and postoperative timepoints (e.g., 6-weeks, 3-months, 6-months, and 1-year). Chi-squared analyses were utilized to assess categorical variables and a Student’s t-tests analyzed continuous variables. A linear regression was used to analyze PROMIS-PF scores from baseline through all postoperative time points. Finally, we evaluated the PROMIS PF achievement of minimal clinically important difference (MCID) among gender.Results192 patients were included: 77 were females and 115 were males. No significant differences were observed among gender subgroups for PROMIS-PF scores at pre- or postoperative evaluations. Compared to males, females experienced significantly greater postoperative improvement with PROMIS-PF scores at the 3-month assessments, though no significant gender differences were observed during later follow-up evaluations at 6-months or one year. Females were observed to have significant PROMIS-PF score improvement from their preoperative evaluation to each postoperative score. Males were assessed to have statistically significant postoperative (e.g., at 3-months, 6-months, and 1-year) PROMIS-PF score improvement from their preoperative PROMIS-PF scores. There were no significant differences among gender in achieving MCID at any postoperative time interval.ConclusionAmong gender, we observed no statistically significant difference in PROMIS-PF scores during the pre- or postoperative evaluations. Additionally, with no difference in the rate of achieving PROMIS-PF MCID postoperatively, this study established that both genders should experience similar functional outcomes following MIS TLIF.     

Mid-term changes in spinopelvic sagittal alignment in lumbar spinal stenosis with coexisting degenerative spondylolisthesis or scoliosis after minimally invasive lumbar decompression surgery: minimum five-year follow-up

BACKGROUND CONTEXTRecently, the number of patients with lumbar spinal stenosis (LSS) who present with a coexisting spinal deformity such as degenerative spondylolisthesis (DS) and scoliosis (DLS) has been increasing. Lumbar decompression without fusion can lead to a reactive improvement in the lumbar and sagittal spinopelvic alignment, even if a sagittal imbalance exists preoperatively. However, the mid- to long-term impact of the coexistence of DS and DLS on the change in sagittal spinopelvic alignment and clinical outcomes after decompression surgery remains unknown.PURPOSEThis study aimed to investigate whether the coexistence of DS or DLS in patients with LSS is associated with differences in radiological and clinical outcomes after minimally invasive lumbar decompression surgery.STUDY DESIGN/SETTINGA retrospective analysis of prospectively collected data.PATIENT SAMPLEA total of 169 patients who underwent minimally invasive lumbar decompression surgery and follow-up >5 years postoperatively.OUTCOME MEASURESSelf-report measures: Low back pain (LBP) and/or leg pain and/or leg numbness visual analog scale (VAS) scores and the Japanese Orthopedic Association scores.PHYSIOLOGIC MEASURESStanding sagittal spinopelvic alignment.METHODSIn total, 81 patients with LSS, 50 patients with LSS and DS (≥3 mm anterior slippage), and 38 patients with LSS and DLS (≥15° coronal Cobb angle) were included in the current study. Clinical and radiological outcome results before surgery and at 2 and 5 years after surgery were compared among the groups.RESULTSIn patients with LSS with coexisting DS, the clinical outcomes at 2, and 5 years after surgery were similar to those of patients with only LSS. In patients with LSS with coexisting DLS, the VAS LBP and leg pain at 2 years after surgery was significantly higher (34.7 vs. 27.8, p=0.014; 27.8 vs. 14.7, p=0.028) and the achievement rate of the minimal clinically important difference in VAS LBP and leg pain was significantly lower than that of the LSS group (36.1% vs. 54.2%, p=0.036; 58.3% vs. 69.9%, p=0.10). The clinical outcomes except VAS leg numbness at 5 years after surgery were similar to those of patients with only LSS. The reoperation rate of the DS group was significantly lower than that of the LSS group (4.0% vs. 14.8%; p=0.01); however, the reoperation rate of the DLS group was comparable to that of the LSS group (15.8% vs. 14.8%; p=0.493). Lumbar lordosis (LL), sacral slope, pelvic tilt, and pelvic incidence-LL had significantly improved and been maintained for 5 years after the surgery in both the DS and the DLS groups. The sagittal vertical axis had improved at two-year follow-up; however, no significant difference was observed at the 5-year follow-up in both the DS, and the DLS groups.CONCLUSIONSMid-term clinical outcomes in patients with LSS with and without deformity were comparable. Lumbar decompression without fusion can result in a reactive improvement in the lumbar and sagittal spinopelvic alignment, even with coexisting DS or DLS. Minimally invasive surgery could be considered for most patients with LSS.     

Characterizing MCID and assessing the role of preoperative PROMIS scores in predicting outcomes for reverse total shoulder arthroplasty at 2-year follow-up

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) has gained more ground as a reliable and efficient means of collecting patient outcomes in different shoulder surgeries. The purpose of this study is to determine if preoperative PROMIS scores are able to predict improvement in postoperative PROMIS scores and anchor this data to determine if a patient will achieve MCID after reverse total shoulder arthroplasty (RTSA). We hypothesize that preoperative PROMIS will significantly correlate, with anchor questions allowing clinicians to predict which patients are most likely to achieve MCID after RTSA.MethodsThree PROMIS CAT forms (PROMIS Upper Extremity Physical Function CAT v2.0 (“PROMIS-UE”), PROMIS Pain Interference v1.1 (“PROMIS-PI”), and PROMIS Depression v1.0 (“PROMIS-D”)) were provided to all patients scheduled to undergo RTSA by board-certified shoulder and elbow surgeons at 1 institution. Demographic data was collected, including age, median household income, zip code, body mass index, sex, smoking status, and race. All patients enrolled in the study were contacted and asked the same 3 anchor questions pertaining to the 3 PROMIS CAT forms above.ResultsA total of 71 patients (52.1% male) were included in our cohort with an average age of 67.8 years (standard deviation, 8.4). Mean follow-up time point was 21.4 months (standard deviation, 9.9) after surgery. Neither preoperative PROMIS-UE, nor preoperative PROMIS-PI showed any significant predictive ability to achieve their respective domain MCIDs (AUC: 0.564 and 0.631, respectively). PROMIS-UE and PROMIS-PI improved to a significant degree at an average 21.4 months postoperatively from 29.2 ± 5.8 and 63.8 ± 4.8 to 39.8.9 ± 8.9 and 50.0 ± 9.7, respectively. Improvements in PRMOIS-D scores were insignificant at average 21.4 months (Baseline: 49.8 ± 8.0 vs. 44.5 ± 9.4 at final follow-up). Using anchor-based analysis to determine MCID, we found the following MCID values for PROMIS-UE, PROMIS-PI, and PROMIS-D: 7.0, -6.6, and -3.9, respectively. ROC analysis revealed MCID values for PROMIS-UE, PI, and D as 7.0, -6.6, and -3.9 respectively (AUC: 0.743, 0.805, 0.601). SCB values for PROMIS-UE, PI, and D were identified as 8.4, -12.1, and -4.0, respectively (AUC: 0.883, 0.932, 0.652).ConclusionsPROMIS-UE and PROMIS-PI questionnaires can adequately assess the symptoms and outcomes of RTSA patients out to two years postoperatively. Preoperative baseline PROMIS-UE, PROMIS-PI, and PROMIS-D scores cannot adequately predict achievement of MCID in patients indicated for primary RTSA when using anchor-based methods at final follow-up, and should not be used to counsel patients on surgery or guide postoperative treatment.Level of EvidenceLevel II; Retrospective Cohort Study     

Preoperative MRI predictors of health-related quality of life improvement after microscopic lumbar discectomy

BACKGROUNDLumbar herniated nucleus pulposus (HNP) is a common spinal pathology often treated by microscopic lumbar discectomy (MLD), though prior reports have not demonstrated which preoperative MRI factors may contribute to significant clinical improvement after MLD.PURPOSETo analyze the MRI characteristics in patients with HNP that predict meaningful clinical improvement in health-related quality of life scores (HRQoL) after MLD.STUDY DESIGN/SETTINGRetrospective clinical and radiological study of patients undergoing MLD for HNP at a single institution over a 2-year period.PATIENT SAMPLEEighty-eight patients receiving MLD treatment for HNP.OUTCOME MEASURESCephalocaudal Canal Migration; Canal & HNP Anterior-Posterior (AP) Lengths and Ratio; Canal & HNP Axial Areas and Ratio; Hemi-Canal & Hemi-HNP Axial Areas and Ratio; Disc appearance (black, gray, or mixed); Baseline (BL); and 3-month (3M) postoperative HRQoL scores.METHODSPatients >18 years old who received MLD for HNP with BL and 3M HRQoL scores of PROMIS (Physical Function, Pain Interference, and Pain Intensity), ODI, VAS Back, and VAS Leg scores were included. HNP and spinal canal measurements of cephalocaudal migration, AP length, area, hemi-area, and disc appearance were performed using T2 axial and sagittal MRI. HNP measurements were divided by corresponding canal measurements to calculate AP, Area, and Hemi-Area ratios. Using known minimal clinically important differences (MCID) for each ΔHRQoL score, patients were separated into two groups based on whether they reached MCID (MCID+) or did not reach MCID (MCID–). The MCID for PROMIS pain intensity was calculated using a decision tree. A linear regression illustrated correlations between PROMIS vs ODI and VAS Back/Leg scores. Independent t-tests and chi-squared tests were utilized to investigate significant differences in HNP measurements between the MCID+ and MCID– groups.RESULTSThere were 88 MLD patients included in the study (Age=44.6±14.9, 38.6% female). PROMIS pain interference and pain intensity were strongly correlated with ODI and VAS Back/Leg (R≥0.505), and physical function correlated with ODI and VAS Back/Leg (R=−0.349) (all p<.01). The strongest MRI predictors of meeting HRQoL MCID were gray disc appearance, HNP area (>116.6 mm²), and Hemi-Area Ratio (>51.8%). MCID+ patients were 2.7 times more likely to have a gray HNP MRI signal than a mixed or black HNP MRI signal in five out of six HRQoL score comparisons (p<.025). MCID+ patients had larger HNP areas than MCID– patients had in five out of six HRQoL score comparisons (116.6 mm²±46.4 vs 90.0 mm²±43.2, p<.04). MCID+ patients had a greater Hemi-Area Ratio than MCID– patients had in four out of six HRQoL score comparisons (51.8%±14.7 vs 43.9%±14.9, p<.05).CONCLUSIONSPatients who met MCID after MLD had larger HNP areas and larger Hemi-HNP Areas than those who did not meet MCID. These patients were also 2.7× more likely to have a gray MRI signal than a mixed or black MRI signal. When accounting for HNP area relative to canal area, patients who met MCID had greater Hemi-HNP canal occupation than patients who did not meet MCID. The results of this study suggest that preoperative MRI parameters can be useful in predicting patient-reported improvement after MLD.     

Preoperative patient activation predicts minimum clinically important difference for PROMIS pain and physical function in patients undergoing elective spine surgery

BACKGROUND CONTEXTPatient activation is a patient's willingness to take independent actions to manage their own health care.PURPOSEThe goal of this study is to determine whether preoperative patient activation measure (PAM) predicts minimum clinically important difference (MCID) for Patient-Reported Outcomes Measurement Information System (PROMIS) pain, physical function, depression, and anxiety for patients undergoing elective spine surgery.STUDY DESIGN/SETTINGRetrospective review.PATIENT SAMPLEA single-institution, academic database of patients undergoing elective spine surgery.OUTCOME MEASUREMCID at 1-year follow-up for PROMIS pain, physical function, depression and anxiety.METHODSWe retrospectively reviewed a single-institution, academic database of patients undergoing elective spine surgery. Preoperative patient activation was evaluated using the PAM-13 survey, which was used to stratify patients into four activation stages. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on PROMIS pain and the physical function.RESULTSOf the 430 patients, 220 (51%) were female with a mean age of 58.2±16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year follow up, 248 (58%) achieved MCID for PROMIS physical function, 256 (60%) achieved MCID for PROMIS pain, 151 (35.28%) achieved MCID for PROMIS depression, and 197 (46%) achieved MCID for PROMIS anxiety. For PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.49, 95% CI:1.27, 9.59), stage 3 (aOR:3.54, 95% CI:1.40, 8.98) and stage 4 (aOR:7.88, 95% CI:3.29, 18.9) were more likely to achieve MCID. For PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.82, 95% CI:1.18, 6.76) and stage 4 (aOR:5.44, 95% CI:2.41, 12.3) were more likely to achieve MCID. For PROMIS depression, when compared against patients at stage 1, patients at stage 4 were more likely to achieve MCID (Adjusted Odds Ratio (aOR):2.59, 95% CI:1.08–6.19). For PROMIS anxiety, when compared against patients at stage 1, stage 3 (Adjusted Odds Ratio (aOR):3.21, 95% CI:1.20–8.57), and stage 4 (aOR:5.56, 95% CI:2.20–14.01) were more likely to achieve MCID.CONCLUSIONPatients at higher stages of activation were more likely to achieve MCID for PROMIS pain, physical function, depression, and anxiety at 1-year follow-up. Routine preoperative assessment of patient activation may help identify patients at risk of poor outcomes.     

Spontaneous correction of sagittal spinopelvic malalignment after decompression surgery without corrective fusion procedure for lumbar spinal stenosis and its impact on clinical outcomes: A systematic review

BackgroundThe impact of a positive sagittal vertical axis (SVA) on the surgical outcome for lumbar spinal stenosis (LSS) remains unclear, because sagittal imbalance in LSS may partly result from the tendency of patients to lean forward to reduce symptoms. Such an abnormality could be normalized by decompression surgery alone without corrective fusion. As this spontaneous correction is not well known, some surgeons perform only neural decompression in patients with positive SVA and decreased lumbar lordosis (LL), unless flatback-related symptoms are present, whereas other surgeons add corrective fusion to restore spinopelvic alignment. We systematically reviewed previous studies on this issue.MethodsPubMed, Cochrane Library, and Embase were searched for English articles on the relationship between SVA and decompression surgery for LSS. The rates of spontaneous correction in spinopelvic parameters and the impact of SVA on clinical outcomes were analyzed.ResultsThe rate of spontaneous SVA correction from >40–50 mm to normal values following decompression surgery alone varied from 25% to 73%. Overall, the spinopelvic parameters tended to improve postoperatively, with statistically significant changes in some series. Postoperative residual sagittal imbalance, rather than preoperative imbalance, more consistently showed a negative impact on clinical outcomes, but not on leg symptoms. For predicting postoperative sagittal imbalance, 2 studies identified the cutoff of >20° for preoperative PI-LL mismatch. Another study suggested SVA >80 mm as a useful value for this purpose.ConclusionIn LSS treated with decompression surgery alone, postoperative rather than preoperative sagittal imbalance more consistently affects clinical outcomes, particularly low back pain. This is probably because decompression usually partly improves preoperative spinopelvic sagittal malalignment. Thus, LSS, if associated with preoperative PI-LL mismatch <20° and SVA <80 mm, may not require additional corrective fusion procedures.     

The necessity and risk factors of subsequent fusion after decompression alone for lumbar spinal stenosis with lumbar spondylolisthesis: 5 years follow-up in two different large populations

BACKGROUND/CONTEXTAlthough decompression without fusion is a reasonable surgical treatment option for some patients with lumbar spinal stenosis (LSS) secondary to spondylolisthesis, some of these patients will require secondary surgery for subsequent fusion. Long-term outcome and need for subsequent fusion in patients treated with decompression alone in the setting of lumbar spondylolisthesis remains controversial.PURPOSEThe aim of this study was to examine the rate, timing, and risk factors of subsequent fusion for patients after decompression alone for LSS with spondylolisthesis.STUDY DESIGN/SETTINGA retrospective cohort study.PATIENT SAMPLEPatients who had LSS with spondylolisthesis and underwent decompression alone at 1 or 2 levels as a primary lumbar surgery with more than 5 year follow-up.OUTCOME MEASURESThe rate, timing, and risk factors for subsequent fusion.METHODSSubjects were extracted from both public and private insurance resources in a nationwide insurer database. Risk factors for subsequent fusion were evaluated by multivariate cox proportion-hazard regression controlling for age, gender, comorbidities and the presence or absence of claudication.RESULTSFive thousand eight hundred and seventy-five patients in the public insurance population (PI population) and 1,456 patients in the private insurance population (PrI population) were included in this study. The rates of patients who needed subsequent fusion were 1.9% at 1 year, 3.5% at 2 years, and 6.7% at 5 years in the PI population, whereas they were 4.3% at 1 year, 8.9% at 2 years, 14.6% at 5 years in the PrI population. The time to subsequent fusion was 730 (365–1234) days in the PI population and 588 (300–998) days in the PrI population. Age less than 70 years, presence of neurogenic claudication and rheumatoid arthritis (RA)/collagen vascular diseases (CVD) were independent risk factors for subsequent fusion in both populations.CONCLUSIONSDecompression surgery alone can demonstrate good outcomes in some patients with LSS with spondylolisthesis. It is important for surgeons to recognize, however, that patient age less than 70 years, symptomatic neurogenic claudication, and presence of RA and/or CVD are significant independent factors associated with greater likelihood of needing secondary fusion surgery.     

Determining minimal clinically important difference estimates following surgery for degenerative conditions of the lumbar spine: analysis of the Canadian Spine Outcomes and Research Network (CSORN) registry

BACKGROUND CONTEXTThere is significant variability in minimal clinically important difference (MCID) criteria for lumbar spine surgery that suggests population and primary pathology specific thresholds may be required to help determine surgical success when using patient reported outcome measures (PROMs).PURPOSEThe purpose of this study was to estimate MCID thresholds for 3 commonly used PROMs after surgical intervention for each of 4 common lumbar spine pathologies.STUDY DESIGN/SETTINGObservational longitudinal study of patients from the Canadian Spine Outcomes and Research Network (CSORN) national registry.PATIENT SAMPLEPatients undergoing surgery from 2015 to 2018 for lumbar spinal stenosis (LSS; n = 856), degenerative spondylolisthesis (DS; n = 591), disc herniation (DH; n = 520) or degenerative disc disease (DDD n = 185) were included.OUTCOME MEASURESPROMs were collected presurgery and 1-year postsurgery: the Oswestry Disability Index (ODI), and back and leg Numeric Pain Rating Scales (NPRS). At 1-year, patients reported whether they were ‘Much better’/’Better’/’Same’/’Worse’/’Much worse’ compared to before their surgery. Responses to this item were used as the anchor in analyses to determine surgical MCIDs for benefit (‘Much better’/‘Better’) and substantial benefit (‘Much better’).METHODSMCIDs for absolute and percentage change for each of the 3 PROMs were estimated using a receiving operating curve (ROC) approach, with maximization of Youden's index as primary criterion. Area under the curve (AUC) estimates, sensitivity, specificity and correct classification rates were determined. All analyses were conducted separately by pathology group.RESULTSMCIDs for ODI change ranged from −10.0 (DDD) to −16.9 (DH) for benefit, and −13.8 (LSS) to −22.0 (DS,DH) for substantial benefit. MCID for back and leg NPRS change were −2 to −3 for each group for benefit and −4.0 for substantial benefit for all groups on back NPRS. MCID estimates for percentage change varied by PROM and pathology group, ranging from −11.1% (ODI for DDD) to −50.0% (leg NPRS for DH) for benefit and from −40.0% (ODI for DDD) to −66.6% (leg NPRS for DH) for substantial benefit. Correct classification rates for all MCID thresholds ranged from 71% to 89% and were relatively lower for absolute vs percent change for those with high or low presurgical scores.CONCLUSIONSOur findings suggest that the use of generic MCID thresholds across pathologies in lumbar spine surgery is not recommended. For patients with relatively low or high presurgery PROM scores, MCIDs based on percentage change, rather than absolute change, appear generally preferable. These findings have applicability in clinical and research settings, and are important for future surgical prognostic work.     

Should patients with lumbar stenosis and grade I spondylolisthesis be treated differently based on spinopelvic alignment? A retrospective,two-year,propensity matched,comparison of patient-reported outcome measures and clinical outcomes from multiple sites within a single health system

BACKGROUNDDegenerative lumbar spondylolisthesis is one of the most common pathologies addressed by surgeons. Recently, data demonstrated improved outcomes with fusion in conjunction with laminectomy compared to laminectomy alone. However, given not all degenerative spondylolistheses are clinically comparable, the best treatment option may depend on multiple parameters. Specifically, the impact of spinopelvic alignment on patient reported and clinical outcomes following fusion versus decompression for grade I spondylolisthesis has yet to be explored.PURPOSEThis study assessed two-year clinical outcomes and one-year patient reported outcomes following laminectomy with concomitant fusion versus laminectomy alone for management of grade I degenerative spondylolisthesis and stenosis. The present study is the first to examine the effect of spinopelvic alignment on patient-reported and clinical outcomes following decompression alone versus decompression with fusion.STUDY DESIGN/SETTINGRetrospective sub-group analysis of observational, prospectively collected cohort study.PATIENT SAMPLE679 patients treated with laminectomy with fusion or laminectomy alone for grade I degenerative spondylolisthesis and comorbid spinal stenosis performed by orthopaedic and neurosurgeons at three medical centers affiliated with a single, tertiary care center.OUTCOME MEASURESThe primary outcome was the change in Patient-Reported Outcome Measurement Information System (PROMIS), Global Physical Health (GPH), and Global Mental Health (GMH) scores at baseline and post-operatively at 4-6 and 10-12 months postoperatively. Secondary outcomes included operative parameters (estimated blood loss and operative time), and two-year clinical outcomes including reoperations, duration of postoperative physical therapy, and discharge disposition.METHODSRadiographs/MRIs assessed stenosis, spondylolisthesis, pelvic incidence, lumbar lordosis, sacral slope, and pelvic tilt; from this data, two cohorts were created based on pelvic incidence minus lumbar lordosis (PILL), denoted as “high” and “low” mismatch. Patients underwent either decompression or decompression with fusion; propensity score matching (PSM) and coarsened exact matching (CEM) were used to create matched cohorts of “cases” (fusion) and “controls” (decompression). Binary comparisons used McNemar test; continuous outcomes used Wilcoxon rank-sum test. Between-group comparisons of changes in PROMIS GPH and GMH scores were analyzed using mixed-effects models; analyses were conducted separately for patients with high and low pelvic incidence-lumbar lordosis (PILL) mismatch.RESULTS49.9% of patients (339) underwent lumbar decompression with fusion, while 50.1% (340) received decompression. In the high PLL mismatch cohort at 10-12 months postoperatively, fusion-treated patients reported improved PROs, including GMH (26.61 vs. 20.75, p<0.0001) and GPH (23.61 vs. 18.13, p<0.0001). They also required fewer months of outpatient physical therapy (1.61 vs. 3.65, p<0.0001) and had lower 2-year reoperation rates (12.63% vs. 17.89%, p=0.0442) compared to decompression-only patients. In contrast, in the low PLL mismatch cohort, fusion-treated patients demonstrated worse endpoint PROs (GMH: 18.67 vs. 21.52, p<0.0001; GPH: 16.08 vs. 20.74, p<0.0001). They were also more likely to require skilled nursing/rehabilitation centers (6.86% vs. 0.98%, p=0.0412) and extended outpatient physical therapy (2.47 vs. 1.34 months, p<0.0001) and had higher 2-year reoperation rates (25.49% vs. 14.71%,p=0.0152).CONCLUSIONSLumbar laminectomy with fusion was superior to laminectomy in health–related quality of life and reoperation rate at two years postoperatively only for patients with sagittal malalignment, represented by high PILL mismatch. In contrast, the addition of fusion for patients with low-grade spondylolisthesis, spinal stenosis, and spinopelvic harmony (low PILL mismatch) resulted in worse quality of life outcomes and reoperation rates.     

Health-related quality of life following decompression compared to decompression and fusion for degenerative lumbar spondylolisthesis: a Canadian multicentre study

Background

Decompression alone (D) is a well-accepted treatment for patients with lumbar spinal stenosis (LSS) causing neurogenic claudication; however, D is controversial in patients with LSS who have degenerative spondylolisthesis (DLS). Our goal was to compare the outcome of anatomy-preserving D with decompression and fusion (DF) for patients with grade I DLS. We compared patients with DLS who had elective primary 1–2 level spinal D at 1 centre with a cohort who had 1–2 level spinal DF at 5 other centres.

Methods

Patients followed for at least 2 years were included. Primary analysis included comparison of change in SF-36 physical component summary (PCS) scores and the proportion of patients achieving minimal clinically important difference (MCID) and substantial clinical benefit (SCB).

Results

There was no significant difference in baseline SF-36 scores between the groups. The average change in PCS score was 10.4 versus 11.4 (p = 0.61) for the D and DF groups, respectively. Sixty-seven percent of the D group and 71% of the DF group attained MCID, while 64% of both D and DF groups attained SCB. There was no significant difference between D and DF for change in PCS score (p = 0.74) or likelihood of reaching MCID (p = 0.81) or SCB (p = 0.85) after adjusting for other variables.

Conclusion

In select patients with DLS, the outcome of D is comparable to DF at a minimum of 2 years.     

Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Forms Demonstrate Responsiveness in Patients Undergoing Knee Arthroplasty

BackgroundThe Patient-Reported Outcomes Measurement Information System (PROMIS) is an alternative to legacy outcome metrics. We investigated the relationship between Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS-JR) and PROMIS Global Health forms of Physical Health (PH) and Mental Health (MH) in knee arthroplasty patients.MethodsThis is a retrospective cohort study of knee arthroplasty patients from December 2017 through April 2019 who had surveys collected preoperatively and postoperatively. We excluded patients undergoing revision surgery. Outcome scores were analyzed for responsiveness, effect size index (ESI), minimal clinically important difference (MCID), and correlation with each other through 12 months postoperatively.ResultsA total of 875 patients were included. Floor and ceiling effects were 0% for PROMIS-PH. Postoperative PROMIS-PH and KOOS-JR scores significantly correlated with one another and increased from baseline at each postoperative time point (P < .001 for all). PROMIS-MH did not change between time points (P > .05). PROMIS-PH showed moderate responsiveness at 1 and 3 months (ESI >0.2) and excellent responsiveness at 6 and 12 months (ESI >0.8), whereas KOOS-JR was responsive at all time points (ESI >0.8). The MCID of PROMIS-PH correlated significantly with KOOS-JR, and a preoperative PROMIS-PH score of less than 32.5 predicted achieving MCID with 97% specificity.ConclusionPROMIS global health forms are a valid metric which capture patient outcomes and correlate with KOOS-JR scores after knee arthroplasty. Although KOOS-JR may be more responsive in the early postoperative time period, both measures show excellent responsiveness at 6 and 12 months after knee arthroplasty.     

Practical answers to frequently asked questions in minimally invasive lumbar spine surgery

BACKGROUND CONTEXTSurgical counseling enables shared decision-making (SDM) by improving patients’ understanding.PURPOSETo provide answers to frequently asked questions (FAQs) in minimally invasive lumbar spine surgery.STUDY DESIGNRetrospective review of prospectively collected data.PATIENT SAMPLEPatients who underwent primary tubular minimally invasive lumbar spine surgery in form of transforaminal lumbar interbody fusion (MI-TLIF), decompression alone, or microdiscectomy and had a minimum of 1-year follow-up.OUTCOME MEASURES(1) Surgical (radiation exposure and intraoperative complications) (2)Immediate postoperative (length of stay [LOS] and complications) (3) Clinical outcomes (Visual Analog Scale- back and leg, VAS; Oswestry Disability Index, ODI; 12-Item Short Form Survey Physical Component Score, SF-12 PCS; Patient-Reported Outcomes Measurement Information System Physical Function, PROMIS PF; Global Rating Change, GRC; return to activities; complications/reoperations)METHODSThe outcome measures were analyzed to provide answers to ten FAQs that were compiled based on the authors’ experience and a review of literature. Changes in VAS back, VAS leg, ODI, and SF-12 PCS from preoperative values to the early (<6 months) and late (>6 months) postoperative time points were analyzed with Wilcoxon Signed Rank Tests. % of patients achieving minimal clinically important difference (MCID) for these patient-reported outcome measures (PROMs) at the two time points was evaluated. Changes in PROs from preoperative values too early (<6 months) and late (≥6 months) postoperative time points were analyzed within each of the three groups. Percentage of patients achieving MCID was also evaluated.RESULTSThree hundred sixty-six patients (104 TLIF, 147 decompression, 115 microdiscectomy) were included. The following FAQs were answered: (1) Will my back pain improve? Most patients report improvement by >50%. About 60% of TLIF, decompression, and microdiscectomy patients achieved MCID at ≥6 months. (2) Will my leg pain improve? Most patients report improvement by >50%. 56% of TLIF, 67% of decompression, and 70% of microdiscectomy patients achieved MCID at ≥6 months. (3) Will my activity level improve? Most patients report significant improvement. Sixty-six percent of TLIF, 55% of decompression, and 75% of microdiscectomy patients achieved MCID for SF-12 PCS. (4) Is there a chance I will get worse? Six percent after TLIF, 14% after decompression, and 5% after microdiscectomy. (5) Will I receive a significant amount of radiation? The radiation exposure is likely to be acceptable and nearly insignificant in terms of radiation-related risks. (6) What is the likelihood that I will have a complication? 17.3% (15.4% minor, 1.9% major) for TLIF, 10% (9.3% minor and 0.7% major) for decompression, and 1.7% (all minor) for microdiscectomy (7) Will I need another surgery? Six percent after TLIF, 16.3% after decompression, 13% after microdiscectomy. (8) How long will I stay in the hospital? Most patients get discharged on postoperative day one after TLIF and on the same day after decompression and microdiscectomy. (9) When will I be able to return to work? >80% of patients return to work (average: 25 days after TLIF, 14 days after decompression, 11 days after microdiscectomy). (10) Will I be able to drive again? >90% of patients return to driving (average: 22 days after TLIF, 11 days after decompression, 14 days after microdiscectomy).CONCLUSIONSThese concise answers to the FAQs in minimally invasive lumbar spine surgery can be used by physicians as a reference to enable patient education.