Measuring clinically relevant improvement after lumbar spine surgery: is it time for something new?

BACKGROUND CONTEXTMinimum clinically important difference (MCID) for patient-reported outcome measures is commonly used to assess clinical improvement. However, recent literature suggests that an absolute point-change may not be an effective or reliable marker of response to treatment for patients with low or high baseline patient-reported outcome scores. The multitude of established MCIDs also makes it difficult to compare outcomes across studies and different spine surgery procedures.PURPOSETo determine whether a 30% reduction from baseline in disability and pain is a valid method for determining clinical improvement after lumbar spine surgery.STUDY DESIGNRetrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database.PATIENT SAMPLEThere were 23,280 participants undergoing elective lumbar spine surgery for degenerative disease who completed a baseline and follow-up assessment at 12 months.OUTCOME MEASURESPatient-reported disability (Oswestry Disability Index [ODI]), back and leg pain (11-point Numeric Rating Scale [NRS]), and satisfaction (NASS scale).METHODSPatients completed baseline and a 12-month postoperative assessment to evaluate the outcomes of disability, pain, and satisfaction. The change in ODI and NRS pain scores was categorized as met (≥30%) or not met (<30%) percent reduction MCID. The 30% reduction from baseline was compared with a wide range of well-established absolute point-change MCID values. The relationship between 30% reduction and absolute change values and satisfaction were primarily compared using receiver operating characteristic (ROC) curves, area under the curve (AUROC), and logistic regression analyses. Analyses were conducted for overall scores and for disability and pain severity categories and by surgical procedure.RESULTSThirty percent reduction in ODI and back and leg pain predicted satisfaction with more accuracy than absolute point-change values for the total population and across all procedure categories (p<.001), except for when compared with the highest absolute point-change threshold for leg pain (3.5-point reduction). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0–20%: 21.8%) and bed-bound disability (ODI 81%–100%: 13.9%) categories. For pain, there was a 3.4%–12.4% and 1.3%–9.8% AUROC difference for no/mild back and leg pain (NRS 0–4), respectively, in favor of a 30% reduction threshold.CONCLUSIONSA 30% reduction MCID either outperformed or was similar to absolute point-change MCID values. Results indicate that a 30% reduction (baseline to 12 months after surgery) in disability and pain is a valid method for determining clinically relevant improvement in a broad spine surgery population. Furthermore, a 30% reduction was most accurate for patients in the lowest and highest disability and lowest pain severity categories. A 30% reduction MCID allows for a standard cut-off for disability and pain that can be used to compare outcomes across various spine surgery procedures.     

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.     

Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma

BackgroundThe Toronto Extremity Salvage Score (TESS) is the most widely used patient-reported outcome measure for orthopaedic oncology patients. However, minimal clinically important differences (MCIDs) in the TESS have not been analyzed. The aim of this study was to define the MCIDs of TESS in patients with lower extremity sarcoma.MethodsA total of 85 patients were investigated to calculate the MCIDs for TESS. Three different methods were used: 1) distribution-based methods based on one-half of the standard deviation and standard error of measurement (SEM) at the baseline, 2) anchor-based and receiver operating characteristic (ROC) analysis, and 3) anchor-based using Akaike's Information Criterion (AIC) analysis.ResultsThe MCIDs at 6 months were 4.9–7.8 by distribution-based methods and 4.3–4.4 by anchor-based methods. The MCIDs at 12 months were 4.0–6.9 by distribution-based methods and 10.6–11.6 by anchor-based methods.ConclusionsWe calculated MCID values for the TESS based on distribution- and anchor-based approaches. Our results seem reasonable since MCIDs calculated by the different approaches had similar values. This knowledge will enable clinicians to identify meaningful functional improvements in sarcoma patients.     

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.     

A Matched Comparison of the Rates of Achieving the Minimal Clinically Important Difference Following Conversion and Primary Total Hip Arthroplasty

BackgroundPatient-reported outcome measures (PROMs) are often lower following conversion total hip arthroplasty (cTHA) compared to matched primary total hip arthroplasty (THA) controls. However, the minimal clinically important differences (MCIDs) for any PROMs are yet to be analyzed for cTHA. This study aimed to (1) determine if patients undergoing cTHA achieve primary THA-specific 1-year PROM MCIDs at comparable rates to matched controls undergoing primary THA and (2) establish 1-year MCID values for specific PROMs following cTHA.MethodsA retrospective case-control study was conducted using 148 cases of cTHA which were matched 1:2 to 296 primary THA patients. Previously defined anchor values for 2 PROM measures in primary THA were used to compare cTHA to primary THA, while novel cTHA-specific MCID values for 2 PROMs were calculated through a distribution method. Predictors of achieving the MCID of PROMs were analyzed through multivariate logistic regressions.ResultsConversion THA was associated with decreased odds of achieving the primary THA-specific 1-year Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement PROM (Odds Ratio: 0.319, 95% Confidence Interval: 0.182-0.560, P < .001) and Patient Reported Outcomes Measurement Information System Physical Function Short-Form-10a PROM (Odds Ratio: 0.531, 95% Confidence Interval: 0.313-0.900, P = .019) MCIDs in reference to matched primary THA patients. Less than 60% of cTHA patients achieved an MCID. The 1-year MCID of the Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement and Patient Reported Outcomes Measurement Information System Physical Function Short-Form-10a specific to cTHA were +10.71 and +4.68, respectively.ConclusionWhile cTHA is within the same diagnosis-related group as primary THA, patients undergoing cTHA have decreased odds of achieving 1-year MCIDs of primary THA-specific PROMs.Level of EvidenceLevel III, retrospective comparative study.     

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.     

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.     

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.     

Clinically meaningful improvement in disabilities of arm,shoulder, and hand (DASH) following cervical spine surgery

BACKGROUND CONTEXTPatients with cervical spine disease suffer from upper limb disability. At present, no clinical benchmarks exist for clinically meaningful change in the upper limb function following cervical spine surgery.PURPOSEPrimary: to establish clinically meaningful metrics; the minimal clinically important difference (MCID) and substantial clinical benefit (SCB) of upper limb functional improvement in patients following cervical spine surgery. Secondary: to identify the prognostic factors of MCID and SCB of upper limb function following cervical spine surgery.STUDY DESIGNRetrospective cohort study.PATIENT SAMPLEAdult patients ≥18 years of age who underwent cervical spine surgery from 2012 to 2016.OUTCOME MEASURESPatient-reported outcomes: Neck disability index (NDI) and Disabilities of Arm, Shoulder, and Hand (DASH).METHODSMCID was defined as minimal improvement and SCB as substantial improvement in the DASH score at last follow-up. The anchor-based methods (ROC analyses) defined optimal MCID and SCB thresholds with area under curve (AUC) in discriminating improved vs. non-improved patients. The MCID was also calculated by distribution-based methods: half standard-deviation (0.5-SD) and standard error of the mean (SEM) method. A multivariable logistic regression evaluated the impact of baseline factors in achieving the MCID and SCB in DASH following cervical spine surgery.RESULTSBetween 2012 and 2016, 1,046 patients with average age of 57±11.3 years, 53% males, underwent cervical spine surgery. Using the ROC analysis, the threshold for MCID was –8 points with AUC of 0.73 (95% CI: 0.67–0.79) and the SCB was –18 points with AUC of 0.88 (95% confidence interval [CI]: 0.85–0.91). The MCID was –11 points by 0.5–SD and –12 points by SEM-method. On multivariable analysis, patients with myelopathy had lower odds of achieving MCID and SCB, whereas older patients and those with ≥6 months duration of symptoms had lower odds of achieving DASH MCID and SCB respectively.CONCLUSIONsIn patients undergoing cervical spine surgery, MCID of –8 points and SCB of –18 points in DASH improvement may be considered clinically significant. These metrics may enable evaluation of minimal and substantial improvement in the upper extremity function following cervical spine surgery.     

Criteria for failure and worsening after surgery for lumbar spinal stenosis: a prospective national spine registry observational study

Background contextCriteria for success after surgical treatment of lumbar spinal stenosis (LSS) have been defined previously; however, there are no clear criteria for failure and worsening after surgery as assessed by patient-reported outcome measures (PROMs).PurposeWe aimed to quantify changes in standard PROMs that most accurately identified failure and worsening after surgery for LSS.Study design /settingRetrospective analysis of prospective national spine registry data with 12-months follow-up.Patient sampleWe analyzed 10,822 patients aged 50 years and older operated in Norway during a decade, and 8,258 (76%) responded 12 months after surgery.Outcome measures (PROMs)We calculated final scores, absolute changes, and percentage changes for Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for back and leg pain (0-10), and EuroQol-5D (EQ-5D). These 12 PROM derivates were compared to the Global Perceived Effect (GPE), a 7-point Likert scale.MethodsWe used ODI, NRS back and leg pain, and EQ-5D 12 months after surgery to identify patients with failure (no effect) and worsening (clinical deterioration). The corresponding GPE at 12-months was graded as failure (GPE=4-7) and worsening (GPE=6-7) and used as an external criterion. To quantify the most accurate cut-off values corresponding to failure and worsening, we calculated areas under the curves (AUCs) of receiver operating characteristics (ROC) curves for the respective PROM derivates.ResultsMean (95% CI) age was 68.3 (68.1 – 68.5) years, and 52% were females. There were 1,683 (20%) failures, and 476 (6%) patients were worse after surgery. The mean (95% CI) pre- and postoperative ODIs were 39.8 (39.5 – 40.2) and 23.7 (23.3 – 24.1), respectively. At 12 months, the mean difference (95% CI) in ODI was 16.1 (15.7 – 16.4), and the mean (95% CI) percentage improvement 38.8% (37.8 – 38.8).The PROM derivates identified failure and worsening accurately (AUC>0.80), except for the absolute change in EQ-5D. The ODI derivates were most accurate to identify both failure and worsening. We found that less than 20% improvement in ODI most accurately identified failure (AUC=0.89 [95% CI: 0.88 to 0.90]), and an ODI final score of 39 points or more most accurately identified worsening (AUC =0.91 [95% CI: 0.90 – 0.92]).ConclusionsIn this national register study, ODI derivates were most accurate to identify both failure and worsening after surgery for degenerative lumbar spinal stenosis. We recommend use of ODI percentage change and ODI final score for further studies of failure and worsening in elective spine surgery.     

Development and validation of machine learning-based predictive model for clinical outcome of decompression surgery for lumbar spinal canal stenosis

BACKGROUND CONTEXTAlthough the results of decompression surgery for lumbar spinal canal stenosis (LSS) are favorable, it is still difficult to predict the postoperative health-related quality of life of patients before surgery.PURPOSEThe purpose of this study was to develop and validate a machine learning model to predict the postoperative outcome of decompression surgery for patients with LSS.STUDY DESIGN/SETTINGA multicentered retrospective study.PATIENT SAMPLEA total of 848 patients who underwent decompression surgery for LSS at an academic hospital, tertiary center, and private hospital were included (age 71±9 years, 68% male, 91% LSS, level treated 1.8±0.8, operation time 69±37 minutes, blood loss 48±113 mL, and length of hospital stay 12±5 days).OUTCOME MEASURESBaseline and 2 years postoperative health-related quality of life.METHODSThe subjects were randomly assigned in a 7:3 ratio to a model building cohort and a testing cohort to test the models’ accuracy. Twelve predictive algorithms using 68 preoperative factors were used to predict each domain of the Japanese Orthopedic Association Back Pain Evaluation Questionnaire and visual analog scale scores at 2 years postoperatively. The final predictive values were generated using an ensemble of the top five algorithms in prediction accuracy.RESULTSThe correlation coefficients of the top algorithms for each domain established using the preoperative factors were excellent (correlation coefficient: 0.95–0.97 [relative error: 0.06–0.14]). The performance evaluation of each Japanese Orthopedic Association Back Pain Evaluation Questionnaire domain and visual analog scale score by the ensemble of the top five algorithms in the testing cohort was favorable (mean absolute error [MAE] 8.9–17.4, median difference [MD] 8.1–15.6/100 points), with the highest accuracy for mental status (MAE 8.9, MD 8.1) and the lowest for buttock and leg numbness (MAE 1.7, MD 1.6/10 points). A strong linear correlation was observed between the predicted and measured values (linear correlation 0.82–0.89), while 4% to 6% of the subjects had predicted values of greater than±3 standard deviations of the MAE.CONCLUSIONSWe successfully developed a machine learning model to predict the postoperative outcomes of decompression surgery for patients with LSS using patient data from three different institutions in three different settings. Thorough analyses for the subjects with deviations from the actual measured values may further improve the predictive probability of this model.     

Minimum clinically important difference for the American Shoulder and Elbow Surgeons score after revision shoulder arthroplasty

BackgroundPatients undergoing revision total shoulder arthroplasty (TSA) typically achieve smaller improvements in outcome measurements than those undergoing primary TSA. The minimum clinically important difference (MCID) in the American Shoulder and Elbow Surgeons (ASES) questionnaire for primary shoulder arthroplasty ranges from 13.6 to 20.9, but the MCID for revision shoulder arthroplasty remains unclear. This study aims to define the MCID in ASES score for revision TSA and ascertain patient factors that affect achieving the MCID threshold.MethodsPatients were identified from an institutional shoulder arthroplasty database. Prospective data collected included demographic variables, prior shoulder surgeries, primary and revision implants, indication for revision, and pre- and postoperative ASES scores. All patients provided informed consent to participate. An anchor-based method was used with a binary answer choice. The MCID was calculated using the receiver-operator curve (ROC) method, and the sensitivity, specificity, and area under the curve were obtained from the ROC. MCID values were compared between groups using Student's t-test. Multivariate logistic regression modeling was used to determine significant predictors for reaching MCID. Significance was defined as P< .05.ResultsA total of 46 patients underwent revision TSA with minimum 2-year follow-up. The MCID using ROC method was 16.7 with 71% sensitivity and 62% specificity. There was a trend toward males being more likely to reach MCID after revision arthroplasty (P= .058). There were also trends toward increased forward flexion and abduction range of motion in patients who met MCID (P= .08, P= .07). Multivariate logistic regression modeling demonstrated male sex to be associated with achieving MCID (P= .03), while younger age and fewer prior shoulder surgeries demonstrated a trend to association with achieving MCID (P= .06, P= .10).ConclusionThe MCID for ASES score in patients undergoing revision shoulder arthroplasty is similar to previously reported MCID values for patients undergoing primary shoulder arthroplasty. Younger, male patients with fewer prior shoulder surgeries were more likely to achieve MCID after revision TSA.Level of EvidenceLevel III; Retrospective Comparative Treatment Study     

Less-invasive decompression procedures can reduce risk of reoperation for lumbar spinal stenosis with diffuse idiopathic skeletal hyperostosis extended to the lumbar segment: analysis of two retrospective cohorts

Purpose

Clinical outcomes after decompression procedures are reportedly worse for lumbar spinal stenosis (LSS) with diffuse idiopathic skeletal hyperostosis (DISH), especially DISH extended to the lumbar segment (L-DISH). However, no studies have compared the effect of less-invasive surgery versus conventional decompression techniques for LSS with DISH. The purpose of this study was to compare the long-term risk of reoperation after decompression surgery focusing on LSS with L-DISH.

Methods

This study compared open procedure cohort (open conventional fenestration) and less-invasive procedure cohort (bilateral decompression via a unilateral approach) with ≥ 5 years of follow-up. After stratified analysis by L-DISH, patients with L-DISH were propensity score-matched by age and sex.

Results

There were 57 patients with L-DISH among 489 patients in the open procedure cohort and 41 patients with L-DISH among 297 patients in the less-invasive procedure cohort. The reoperation rates in L-DISH were higher in the open than less-invasive procedure cohort for overall reoperations (25% and 7%, p = 0.026) and reoperations at index levels (18% and 5%, p = 0.059). Propensity score-matched analysis in L-DISH demonstrated that open procedures were significantly associated with increased overall reoperations (hazard ratio [HR], 6.18; 95% confidence interval [CI], 1.37–27.93) and reoperations at index levels (HR, 4.80; 95% CI, 1.04–22.23); there was no difference in reoperation at other lumbar levels.

Conclusions

Less-invasive procedures had a lower risk of reoperation, especially at index levels for LSS with L-DISH. Preserving midline-lumbar posterior elements could be desirable as a decompression procedure for LSS with L-DISH.

     

Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit

Background

The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However, the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context, the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments, patient satisfaction and cost-effectiveness.

Methods

Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI, PCS, MCS and VAS) were collected preoperatively, and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS, HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen.

Results

On average, all patients presented with a statistically significant improvement (p?<?0.001) postoperatively for NDI (27.42 to 19.42), PCS (33.02 to 42.03), MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23–16.59 for PCS, 0.11–16.27 for MCS and 2.72–12.08 for NDI. When compared to the VAS and HTI anchors, the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation.

Conclusion

The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI), and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS, 5.12 for MCS and 2.41 for NDI.     

The critical cutoff point of the Zurich Claudication Questionnaire and the Japanese Orthopaedic Association score indicating locomotive syndrome in patients with lumbar spinal canal stenosis

BackgroundLocomotive syndrome (LS) is a condition of decreased mobility caused by disorders of the locomotive organs. Lumbar spinal stenosis (LSS) is a LS disorder. The Japanese Orthopaedic Association score (JOA score) and the Zurich Claudication Questionnaire (ZCQ) are international evaluation tools for LSS. However, the relationship between LS and JOA score or ZCQ is unknown. This study aimed to clarify the correlations between LS progression and the values/parameters of the JOA score or ZCQ and to determine the critical cutoff point of the JOA score or ZCQ that indicates LS progression.MethodsWe recruited preoperative LSS patients (n = 82). Patients' mean age was 73.4 years. The study participants were evaluated using the 25-question Geriatric Locomotive Function Scale (GLFS), JOA score, and ZCQ (which consists of symptom severity and physical function), and the patients' health-related quality of life was assessed using EuroQoL-5 dimension (EQ-5D) utility values and the EuroQoL-visual analog scale (EQ-VAS). We investigated the correlations between the 25-question GLFS and each clinical variable and evaluated the critical cutoff point of each international evaluation tool to detect LS.ResultsThere was a statistically significant correlation between 25-question GLFS and each clinical evaluation tool. LSS patients with LS showed significantly worse scores in the evaluation tools than LSS patients without LS. Moreover, we found that critical cutoff points of 17.5 on JOA score, 3.1 on ZCQ-symptom, and 2.3 on ZCQ-function could detect LS.ConclusionsA statistically significant correlation exists between the 25-question GLFS and the JOA score or ZCQ. It might be important to perform decompression surgery for LSS patients before they reach the cutoff values of the several clinical evaluation tools to avoid LS progression.Study designClinical prospective case–control study.     

Characteristics and outcomes of patients undergoing lumbar spine surgery for axial back pain in the Michigan Spine Surgery Improvement Collaborative

BACKGROUND CONTEXTThe indications for surgical intervention of axial back pain without leg pain for degenerative lumbar disorders have been limited in the literature, as most study designs allow some degree of leg symptoms in the inclusion criteria.PURPOSETo determine the outcome of surgery (decompression only vs. fusion) for pure axial back pain without leg pain.STUDY DESIGN/SETTINGProspectively collected data in the Michigan Spine Surgery Improvement Collaborative (MSSIC).PATIENT SAMPLEPatients with pure axial back pain without leg pain underwent lumbar spine surgery for primary diagnoses of lumbar disc herniation, lumbar stenosis, and isthmic or degenerative spondylolisthesis ≤ grade II.OUTCOME MEASURESMinimally clinically important difference (MCID) for back pain, Numeric Rating Scale of back pain, Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF), MCID of PROMIS-PF, and patient satisfaction on the North American Spine Surgery Patient Satisfaction Index were collected at 90 days, 1 year, and 2 years after surgery.METHODSLog-Poisson generalized estimating equation models were constructed with patient-reported outcomes as the independent variable, reporting adjusted risk ratios (RR_adj).RESULTSOf the 388 patients at 90 days, multi-level versus single level lumbar surgery decreased the likelihood of obtaining a MCID in back pain by 15% (RR_adj=0.85, p=.038). For every one-unit increase in preoperative back pain, the likelihood for a favorable outcome increased by 8% (RR_adj=1.08, p<.001). Of the 326 patients at 1 year, symptom duration > 1 year decreased the likelihood of a MCID in back pain by 16% (RR_adj=0.84, p=.041). The probability of obtaining a MCID in back pain increased by 9% (RR_adj=1.09, p<.001) for every 1-unit increase in baseline back pain score and by 14% for fusions versus decompression alone (RR_adj=1.14, p=.0362). Of the 283 patients at 2 years, the likelihood of obtaining MCID in back pain decreased by 30% for patients with depression (RR_adj=0.70, p<.001) and increased by 8% with every one-unit increase in baseline back pain score (RR_adj=1.08, p<.001).CONCLUSIONSOnly the severity of preoperative back pain was associated with improvement in MCID in back pain at all time points, suggesting that surgery should be considered for selected patients with severe axial pain without leg pain. Fusion surgery versus decompression alone was associated with improved patient-reported outcomes at 1 year only, but not at the other time points.     

Minimum clinically important difference of the health-related quality of life scales in adult spinal deformity calculated by latent class analysis: is it appropriate to use the same values for surgical and nonsurgical patients?

BACKGROUND CONTEXT

Health-related quality of life (HRQOL) parameters have been shown to be reliable and valid in patients with adult spinal deformity (ASD). Minimum clinically important difference (MCID) has become increasingly important to clinicians in evaluating patients with a threshold of improvement that is clinically relevant.

The effect of frailty on the quality of life and lower urinary symptoms following robot-assisted radical prostatectomy: A longitudinal analysis (FRARP-QL Study)

ObjectivesWe aimed to evaluate the effect of frailty on health-related quality-of-life (HRQOL) and lower urinary symptoms (LUTS) following robot-assisted radical prostatectomy (RARP) in patients with prostate cancer (CaP).Materials and MethodsWe longitudinally evaluated geriatric 8 (G8), HRQOL, and LUTS for 12 months in 118 patients with RARP from January 2017 to April 2020. Patients were divided into frail (G8 ≤14) and nonfrail (G8 >14) groups. We compared the effect of frailty on HRQOL and LUTS between the frail and nonfrail groups before and 12 months after RARP.ResultsThe median age of patients was 68 years. The number of patients in the frail and nonfrail groups were 41 and 77, respectively. No significant difference in patients’ background was observed between the groups, except for the presence of cardiovascular disease (22% vs. 7.8%, P = 0.041). There was no significant difference in HRQOLs and LUTS between the groups at baseline. Similarly, HRQOLs, LUTS, and pad-free continence rates were not significantly different between the groups at 12 months after RARP. In the nonfrail group, LUTS at 12 months following RARP significantly improved compared to those at the baseline, but it did not significantly improve in the frail group. Multivariable logistic regression analysis demonstrated that frailty was not significantly associated with LUTS worsening.ConclusionsFrailty was not significantly associated with the worsening of HRQOL, LUTS, and pad-free continence rates in patients treated with RARP.     

Health related quality of life outcomes following surgery and/or radiation for patients with potentially unstable spinal metastases

BACKGROUNDCurrently there is no prospective pain and health related quality of life (HRQOL) data of patients with potentially unstable spinal metastases who were treated with surgery ± radiation or radiation alone.METHODSAn international prospective cohort multicenter study of patients with potentially unstable spinal metastases, defined by a SINS score 7 to 12, treated with surgery ± radiation or radiotherapy alone was conducted. HRQOL was evaluated with the numeric rating scale (NRS) pain score, the SOSGOQ2.0, the SF-36, and the EQ-5D at baseline and 6, 12, 26, and 52 weeks after treatment.RESULTSA total of 136 patients were treated with surgery ± radiotherapy and 84 with radiotherapy alone. At baseline, surgically treated patients were more likely to have mechanical pain, a lytic lesion, a greater median Spinal Instability Neoplastic score, vertebral compression fracture, lower performance status, HRQOL, and pain scores. From baseline to 12 weeks post-treatment, surgically treated patients experienced a 3.0-point decrease in NRS pain score (95% CI ?4.1 to ?1.9, p<.001), and a 12.7-point increase in SOSGOQ2.0 score (95% CI 6.3–19.1, p<.001). Patients treated with radiotherapy alone experienced a 1.4-point decrease in the NRS pain score (95% CI ?2.9 to 0.0, p=.046) and a 6.2-point increase in SOSGOQ2.0 score (95% CI ?2.0 to 14.5, p=.331). Beyond 12 weeks, significant improvements in pain and HRQOL metrics were maintained up to 52-weeks follow-up in the surgical cohort, as compared with no significant changes in the radiotherapy alone cohort.CONCLUSIONSPatients treated with surgery demonstrated clinically and statistically significant improvements in pain and HRQOL up to 1-year postsurgery. Treatment with radiotherapy alone resulted in improved pain scores, but these were not sustained beyond 3 months and HRQOL outcomes demonstrated nonsignificant changes over time. Within the SINS potentially unstable group, distinct clinical profiles were observed in patients treated with surgery or radiotherapy alone.