Background Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) for lumbar spondylolisthesis allows for the surgical treatment of back/leg pain while minimizing tissue injury and ...accelerating the patient's recovery. Although previous results have shown shorter hospital stays and decreased intraoperative blood loss for MIS versus open TLIF, short- and long-term outcomes have been similar. Therefore, we performed comparative effectiveness and cost-utility analysis for MIS versus open TLIF. Methods A total of 100 patients (50 MIS, 50 open) undergoing TLIF for lumbar spondylolisthesis were prospectively studied. Back-related medical resource use, missed work, and quality-adjusted life years were assessed. Cost of in-patient care, direct cost (2-year resource use × unit costs based on Medicare national allowable payment amounts), and indirect cost (work-day losses × self-reported gross-of-tax wage rate) were recorded, and the incremental cost-effectiveness ratio was calculated. Results Length of hospitalization and time to return to work were less for MIS versus open TLIF ( P = 0.006 and P = 0.03, respectively). MIS versus open TLIF demonstrated similar improvement in patient-reported outcomes assessed. MIS versus open TLIF was associated with a reduction in mean hospital cost of $1758, indirect cost of $8474, and total 2-year societal cost of $9295 ( P = 0.03) but similar 2-year direct health care cost and quality-adjusted life years gained. Conclusions MIS TLIF resulted in reduced operative blood loss, hospital stay and 2-year cost, and accelerated return to work. Surgical morbidity, hospital readmission, and short- and long-term clinical effectiveness were similar between MIS and open TLIF. MIS TLIF may represent a valuable and cost-saving advancement from a societal and hospital perspective.
Abstract Background context Spinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the ...extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis. Purpose To determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis. Study design/ setting Retrospective cohort study. Methods In 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index). Results All patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state. Conclusions Using subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.
Background
Long-term postdiscectomy degenerative disc disease and low back pain is a well-recognized disorder; however, its patient-centered characterization and quantification are lacking.
...Questions/purposes
We performed a systematic literature review and prospective longitudinal study to determine the frequency of recurrent back pain after discectomy and quantify its effect on patient-reported outcomes (PROs).
Methods
A MEDLINE search was performed to identify studies reporting on the frequency of recurrent back pain, same-level recurrent disc herniation, and reoperation after primary lumbar discectomy. After excluding studies that did not report the percentage of patients with persistent back or leg pain more than 6 months after discectomy or did not report the rate of same level recurrent herniation, 90 studies, which in aggregate had evaluated 21,180 patients, were included in the systematic review portion of this study. For the longitudinal study, all patients undergoing primary lumbar discectomy between October 2010 and March 2013 were enrolled into our prospective spine registry. One hundred fifteen patients were more than 12 months out from surgery, 103 (90%) of whom were available for 1-year outcomes assessment. PROs were prospectively assessed at baseline, 3 months, 1 year, and 2 years. The threshold of deterioration used to classify recurrent back pain was the minimum clinically important difference in back pain (Numeric Rating Scale Back Pain NRS-BP) or Disability (Oswestry Disability Index ODI), which were 2.5 of 10 points and 20 of 100 points, respectively.
Results Systematic Review
The proportion of patients reporting short-term (6–24 months) and long-term (> 24 months) recurrent back pain ranged from 3% to 34% and 5% to 36%, respectively. The 2-year incidence of recurrent disc herniation ranged from 0% to 23% and the frequency of reoperation ranged from 0% to 13%.
Prospective Study
At 1-year and 2-year followup, 22% and 26% patients reported worsening of low back pain (NRS: 5.3 ± 2.5 versus 2.7 ± 2.8, p < 0.001) or disability (ODI%: 32 ± 18 versus 21 ± 18, p < 0.001) compared with 3 months.
Conclusions
In a systematic literature review and prospective outcomes study, the frequency of same-level disc herniation requiring reoperation was 6%. Two-year recurrent low back pain may occur in 15% to 25% of patients depending on the level of recurrent pain considered clinically important, and this leads to worse PROs at 1 and 2 years postoperatively.
Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome (PRO) questionnaires. Although these questionnaires assess pain, disability, and general ...health state, their numerical scores lack direct, clinically significant meaning. Thus, the concept of minimum clinically important difference (MCID) has been introduced, which indicates the smallest change in an outcome measure that reflects clinically meaningful improvement to patients. The authors set out to determine anterior cervical discectomy and fusion (ACDF)-specific MCID values for the visual analog scale (VAS), Neck Disability Index (NDI), 12-Item Short-Form Health Survey (SF-12), and EQ-5D (the EuroQol health survey) in patients undergoing ACDF for cervical radiculopathy.
Data on 69 patients who underwent ACDF for cervical radiculopathy were collected in the authors' web-based, prospective registry during the study enrollment period. Patient-reported outcome questionnaires (VAS-neck pain NP), VAS-arm pain AP, NDI, SF-12, and EQ-5D) were administered preoperatively and 3 months postoperatively, allowing 3-month change scores to be calculated. Four established calculation methods were used to calculate anchor-based MCID values using the North American Spine Society (NASS) patient satisfaction scale as the anchor: 1) average change, 2) minimum detectable change (MDC), 3) change difference, and 4) receiver operating characteristic (ROC) curve analysis.
Sixty-one patients (88%) were available at follow-up. At 3 months postoperatively, statistically significant improvement (p < 0.001) was observed for the following PROs assessed: VAS-NP (2.7 ± 3.3), VAS-AP (3.7 ± 3.6), NDI (23.2% ± 19.7%), SF-12 physical component score (PCS; 10.7 ± 9.7), and EQ-5D (0.20 ± 0.23 QALY). Improvement on the SF-12 mental component score (MCS) trended toward significance (3.4 ± 11.4, p = 0.07). The 4 MCID calculation methods generated a range of MCID values for each of the PROs: VAS-NP 2.6-4.0, VAS-AP 2.4-4.2, NDI 16.0%-27.6%, SF-12 PCS 7.0-12.2, SF-12 MCS 0.0-7.2, and EQ-5D 0.05-0.24 QALY. The maximum area under the curve (AUC) was observed for NDI (0.80), and the minimum AUC was observed for SF-12 MCS (0.66) and EQ-5D (0.67). Based on the MDC approach, the MCID threshold was 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D. The mean improvement in patient scores at 3 months surpassed the MCID threshold for VAS-NP, NDI, and SF-12 PCS but not for VAS-AP, SF-12 MCS, and EQ-5D.
The ACDF-specific MCID is highly variable depending on the calculation technique used. The MDC approach seems to be most appropriate for MCID calculations in the ACDF population, as it provided a threshold value above the 95% confidence interval of nonresponders (greater than the measurement error) and was closest to the average change of most PROs reported by responders. When the MDC method was applied with the NASS patient satisfaction scale as the anchor, the MCID thresholds were 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D.
Abstract Background context Only Level 3 evidence exists for the diagnosis and treatment of atlantooccipital dislocation (AOD) with few studies examining mortality, neurologic improvement, and ...patient-reported outcomes (PROs). Purpose First, the aim was to determine: the incidence of AOD, 90-day surgical morbidity and mortality after AOD, patient factors that may be associated with delayed or missed diagnosis, and factors that were associated with mortality and neurologic improvement after AOD. Secondly, the aim was to quantify the pain, disability, and quality of life experienced by patients surviving AOD. Study design/setting This was a retrospective cohort study. Patient sample A total of 5,337 consecutive spine computed tomography traumagrams from 1997 to 2012 were included. Outcome measures Mortality, neurologic improvement, complications, EuroQol five dimensions (EQ-5D), Neck Disability Index (NDI), Numeric Rating Scale (NRS)-neck, NRS-arm, and return-to-work were the outcome measures. Methods Patients were considered to have AOD if they met one of the following radiographic criteria: basion-dens interval greater than 10 mm; basion-axial interval: anterior displacement greater than 12 mm or posterior displacement greater than 4 mm between the basion and posterior C2 line; and condyle to C1 interval greater than 1.4 mm. Linear regression analysis was performed to identify factors associated with 90-day mortality, neurologic improvement, and missed diagnosis. Patient-reported outcomes were assessed via phone interview. Results Thirty-one patients met radiographic criteria for AOD; an incidence of 0.6% over 15 years. Twenty-one (68%) patients were treated with occipital cervical fusion. At 90 days postoperatively, there were no new neurologic deficits or reoperations. Eight (26%) patients died within 90 days. All patients who died had no documented AOD diagnosis and were not treated surgically. Missed AOD diagnosis was the strongest predictor of mortality. Younger age, lower Glasgow Coma Score, lower Injury Severity Score (ISS) score, and worse initial American Spinal Injury Association (ASIA) score were significantly associated with greater neurologic improvement. Higher ISS score and better ASIA score were significantly associated with missed AOD diagnosis. The average PROs metrics at time of telephone follow-up were as follows: EQ-5D=0.73±0.19, NDI=30.89±18.57, NRS-neck=2.33±2.21, NRS-arm=2.00±2.54. Of the patients with follow-up data, four were employed full-time, and five were receiving disability. Conclusions Our work suggests that failure to diagnose AOD is a powerful predictor of mortality. Higher ISS scores and better neurologic presentation were significantly associated with missed diagnosis. Craniocervical arthrodesis preserved neurologic function with low complication rate and unexpectedly high PROs and return-to-work. These results must be carefully interpreted because it is unclear whether missed AOD diagnosis accompanies another death-causing injury (eg, traumatic brain injury) or if failure to treat AOD contributes to mortality in a multifactorial manner.
Abstract Background context Given the unsustainable costs of the US health-care system, health-care purchasers, payers, and hospital systems are adopting the concept of value-based purchasing by ...shifting care away from low-quality providers or hospitals. Legislation now allows public reporting of these quality rankings. True measures of quality, such as surgical morbidity and validated questionnaires of effectiveness, are burdensome and costly to collect. Hence, patients' satisfaction with care has emerged as a commonly used metric as a proxy for quality because of its feasibility of collection. However, patient satisfaction metrics have yet to be validated as a measure of overall quality of surgical spine care. Purpose We set out to determine whether patient satisfaction is a valid measure of safety and effectiveness of care in a prospective longitudinal spine registry. Study design Prospective longitudinal cohort study. Patient population All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center. Outcome measures Patient-reported outcome instruments (numeric rating scale NRS, Oswestry disability index ODI, neck disability index NDI, short-form 12-item survey SF-12, Euro-Qol-5D EQ-5D, Zung depression scale, and Modified Somatic Perception Questionnaire MSPQ anxiety scale), return to work, patient satisfaction with outcome , and patient satisfaction with provider care. Methods All patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center were enrolled into a prospective longitudinal registry. Data collected on all patients included demographics, disease characteristics, treatment variables, readmissions/reoperations, and all 90-day surgical morbidity. Patient-reported outcome instruments (NRS, ODI, NDI, SF-12, EQ-5D, Zung depression scale, and MSPQ anxiety scale), return to work, patient satisfaction with outcome, and patient satisfaction with provider care were recorded at baseline and 3 months after treatment. Receiver-operating characteristic (ROC) curve analysis was performed to determine whether extent of improvement in quality of life (SF-12 physical component summary PCS) and disability (ODI/NDI) accurately predicted patient satisfaction versus dissatisfaction. Standard interpretation of area under the curve (AUC) was used: less than 0.7, poor; 0.7 to 0.8, fair; and greater than 0.8, good accuracy. Multivariate logistic regression analysis was performed to determine if surgical morbidity (quality) or improvement in disability and quality of life (effectiveness of care) were independently associated with patient satisfaction. Results Four hundred twenty-two (84%) patients completed all questionnaires 3 months after surgery during the reviewed time period (mean age 55±14 years). Lumbar surgery was performed in 287 (68%) and cervical surgery in 135 (32%) patients. There were 51 (12.1%) 90-day complications, including 21 (5.0%) readmissions and 12 (2.8%) return to operating room. Three hundred fifty-eight (84.8%) patients were satisfied with provider care and 288 (68.2%) with their outcome. Satisfaction with provider care: In ROC analyses, extent of improvement in quality of life (SF-12) and disability (ODI/NDI) differentiated satisfaction versus dissatisfaction with care with very poor accuracy (AUC 0.49–0.69). In regression analysis, 3-month morbidity (odds ratio 95% confidence interval: 1.45 0.79–2.66), readmission (0.66 0.24–1.80), improvement in quality of life (SF-12 PCS), or improvement in general health (health transition index) were not associated with satisfaction with care. Satisfaction with outcome: In ROC analyses, improvement in quality of life (SF-12) and disability (ODI/NDI) failed to differentiate satisfaction with good accuracy (AUC 0.76). Neither 90-day morbidity (1.05 0.46–2.34) nor 90-day readmission (0.27 0.04–2.04) was associated with satisfaction with outcome in regression analysis. Conclusions Patient satisfaction is not a valid measure of overall quality or effectiveness of surgical spine care. Patient satisfaction metrics likely represent the patient's subjective contentment with health-care service, a distinct aspect of care. Satisfaction metrics are important patient-centered measures of health-care service but should not be used as a proxy for overall quality, safety, or effectiveness of surgical spine care.
Abstract Background context Persistent back pain and leg pain after index surgery is distressing to patients and spinal surgeons. Revision surgical treatment is technically challenging and has been ...reported to yield unpredictable outcomes. Recently, affective disorders, such as depression and anxiety, have been considered potential predictors of surgical outcomes across many disease states of chronic pain. There remains a paucity of studies assessing the predictive value of baseline depression on outcomes in the setting of revision spine surgery. Purpose To assess the predictive value of preoperative depression on 2-year postoperative outcome after revision lumbar surgery for symptomatic pseudarthrosis, adjacent segment disease (ASD), and same-level recurrent stenosis. Study design Retrospective cohort study. Patient sample One hundred fifty patients undergoing revision surgery for symptomatic ASD, pseudarthrosis, and same-level recurrent stenosis. Outcome measures Patient-reported outcome measures were assessed using an outcomes questionnaire that included questions on health-state values (EQ-5D), disability (Oswestry Disability Index ODI), pain (visual analog scale), depression (Zung Self-Rating Depression Scale), and 12-Item Short Form Health Survey physical and mental component scores. Methods One hundred fifty patients undergoing revision neural decompression and instrumented fusion for ASD (n=50), pseudarthrosis (n=47), or same-level recurrent stenosis (n=53) were included in this study. Preoperative Zung Self-Reported Depression Scale score was assessed for all patients. Preoperative and 2-year postoperative visual analog scale for back pain and leg pain scores and ODI were assessed. The association between preoperative Zung Depression Scale score and 2-year improvement in disability was assessed via multivariate regression analysis. Results Compared to preoperative status, VAS-BP was significantly improved 2 years after surgery for ASD (8.72±1.85 vs. 3.92±2.84, p=.001), pseudoarthrosis (7.31±0.81 vs. 5.06±2.64, p=.001), and same-level recurrent stenosis (9.28±1.00 vs. 5.00±2.94, p=.001). Two-year ODI was also significantly improved after surgery for ASD (28.72±9.64 vs. 18.48±11.31, p=.001), pseudoarthrosis (29.74±5.35 vs. 25.42±6.00, p=.001), and same-level recurrent stenosis (36.01±6.00 vs. 21.75±12.07, p=.001). Independent of age, BMI, symptom duration, smoking, comorbidities, and level of preoperative pain and disability, increasing preoperative Zung depression score was significantly associated with less 2-year improvement in disability (ODI) after revision surgery for ASD, pseudoarthrosis, and recurrent stenosis. Conclusions Our study suggests that the extent of preoperative depression is an independent predictor of functional outcome after revision lumbar surgery for ASD, pseudoarthrosis, and recurrent stenosis. Future comparative effectiveness studies assessing outcomes after revision lumbar surgery should account for depression as a potential confounder. The Zung depression questionnaire may help risk stratify patients presenting for revision lumbar surgery.
Current health care reform calls for a reduction of procedures and treatments that are less effective, more costly, and of little value (high cost/low quality). The authors assessed the 2-year cost ...and effectiveness of comprehensive medical management for lumbar spondylolisthesis, stenosis, and herniation by utilizing a prospective single-center multidisciplinary spine center registry in a real-world practice setting.
Analysis was performed on a prospective longitudinal quality of life spine registry. Patients with lumbar spondylolisthesis (n = 50), stenosis (n = 50), and disc herniation (n = 50) who had symptoms persisting after 6 weeks of medical management and who were eligible for surgical treatment were entered into a prospective registry after deciding on nonsurgical treatment. In all cases, comprehensive medical management included spinal steroid injections, physical therapy, muscle relaxants, antiinflammatory medication, and narcotic oral agents. Two-year patient-reported outcomes, back-related medical resource utilization, and occupational work-day losses were prospectively collected and used to calculate Medicare fee-based direct and indirect costs from the payer and societal perspectives. The maximum health gain associated with medical management was defined as the improvement in pain, disability, and quality of life experienced after 2 years of medical treatment or at the time a patient decided to cross over to surgery.
The maximum health gain in back pain, leg pain, disability, quality of life, depression, and general health state did not achieve statistical significance by 2 years of medical management, except for pain and disability in patients with disc herniation and back pain in patients with lumbar stenosis. Eighteen patients (36%) with spondylolisthesis, 11 (22%) with stenosis, and 17 (34%) with disc herniation eventually required surgical management due to lack of improvement. The 2-year improvement did not achieve a minimum clinically important difference in any outcome measure. The mean 2-year total cost (direct plus indirect) of medical management was $6606 for spondylolisthesis, $7747 for stenosis, and $7097 for herniation.
In an institution-wide, prospective, longitudinal quality of life registry that measures cost and effectiveness of all spine care provided, comprehensive medical management did not result in sustained improvement in pain, disability, or quality of life for patients with surgically eligible degenerative lumbar spondylolisthesis, stenosis, or disc herniation. From both the societal and payer perspective, continued medical management of patients with these lumbar pathologies in whom 6 weeks of conservative therapy failed was of minimal value given its lack of health utility and effectiveness and its health care costs. The findings from this real-world practice setting may more accurately reflect the true value and effectiveness of nonoperative care in surgically eligible patient populations.
Abstract Background context Patient satisfaction ratings are increasingly being used in health care as a proxy for quality and are becoming the focal point for several quality improvement ...initiatives. Affective disorders, such as depression, have been shown to influence patient-reported outcomes and self-interpretation of health status. We hypothesize that patient psychiatric profiles influence reported satisfaction with care, independent of surgical effectiveness. Purpose To assess the predictive value of preoperative depression on patient satisfaction after revision surgery for same-level recurrent stenosis. Study design Retrospective cohort study. Patient sample Fifty-three patients undergoing a revision surgery for symptomatic same-level recurrent stenosis. Outcome measures Patient-reported outcome measures were assessed using an outcomes questionnaire that included questions on health state values (EuroQol-5D EQ-5D), disability (Oswestry Disability Index ODI), pain (visual analog scale VAS), depression (Zung self-rating depression scale), and Short Form 12 (SF-12) physical and mental component scores (PCS and MCS). Patient satisfaction was dichotomized as either “YES” or “NO” on whether they were satisfied with their surgical outcome 2 years after the surgery. Methods A total of fifty-three patients undergoing revision neural decompression and instrumented fusion for same-level recurrent stenosis-associated back and leg pain were included in this study. Preoperative Zung self-rating depression score (ZDS), education status, comorbidities, and postoperative satisfaction with surgical care and outcome was assessed for all patients. Baseline and 2-year VAS for leg pain (VAS-LP), VAS for low back pain (VAS-BP), ODI, SF-12 PCS and MCS, and health-state utility (EQ-5D) were assessed. Factors associated with patient satisfaction after surgery were assessed via multivariate logistic regression analysis. Results Two years after surgery, a significant improvement was reported in all outcome measures: VAS-BP (5±2.94 vs. 9.28±1, p<.001), VAS-LP (3.43±2.95 vs. 9.5±0.93, p<.001), ODI (21.75±12.07 vs. 36.01±6, p<.001), SF-12 PCS (32.30±11.01 vs. 25.13±5.84, p<.001), SF-12 MCS (47.48±10.96 vs. 34.91±12.77, p<.001), EQ-5D (0.60±0.31 vs. 0.18±0.22, p<.001), and ZDS (37.52±11.98 vs. 49.90±10.88, p<.001). Independent of postoperative improvement in pain and disability (surgical effectiveness), increasing preoperative Zung depression score was significantly associated with patient dissatisfaction 2 years after revision lumbar surgery (Odds ratio=0.67 confidence interval: 0.38, 0.87, p<.001). Conclusions Our study suggests that independent of the surgical effectiveness, the extent of preoperative depression influences the reported patient satisfaction after revision lumbar surgery. Quality improvement initiatives using patient satisfaction as a proxy for quality should account for the patients' baseline depression as potential confounders.
Abstract Background context There is a growing demand to measure the real-world effectiveness and value of care across all specialties and disease states. Prospective registries have emerged as a ...feasible way to capture real-world care across large patient populations. However, the proven validity of more robust and cumbersome patient-reported outcome instruments (PROi) must be balanced with what is feasible to apply in large-scale registry efforts. Hence, commercial registry efforts that measure quality and effectiveness of care in an attempt to guide quality improvement, pay for performance, or value-based purchasing should incorporate measures that most accurately represent patient-centered improvement. Purpose We set out to establish the relative validity and responsiveness of common PROi in accurately determining effectiveness of cervical surgery for neck and arm pain in registry efforts. Study design Prospective cohort study. Patient sample Eighty-eight patients undergoing primary anterior cervical discectomy and fusion (ACDF) for neck and arm pain. Outcome measures Patient-reported outcome measures for pain (numeric rating scale for neck pain NRS-NP and arm pain NRS-AP), disability (neck disability index NDI), general health (short-form 12-item survey physical component summary SF-12 PCS and mental component summary SF-12 MCS), and quality of life (Euro-Qol-5D EQ-5D) were assessed. Methods Eighty-eight patients undergoing primary ACDF for neck and arm pain were entered into a Web-based prospective registry. Baseline and 12-month patient-reported outcomes (NRS-NP, NRS-AP, NDI, SF-12 PCS, SF-12 MCS, and EQ-5D) were assessed. Patients were also asked whether they experienced a level of improvement after ACDF that met their expectation (meaningful improvement). To assess the validity of NRS-NP, NRS-AP, and NDI (measures of pain and disability) to discriminate between meaningful and nonmeaningful improvement and the validity of SF-12 PCS, SF-12 MCS, and EQ-5D (measures of general health and quality of life) to discriminate between meaningful and nonmeaningful improvement, receiver-operating characteristic curves were generated for each outcome instrument. The greater the area under the curve (AUC), the more valid the discriminator. The difference between standardized response means (SRMs) in patients reporting meaningful improvement versus not was calculated to determine the relative responsiveness of each outcome instrument to changes in pain and QOL after surgery. Results For pain and disability, both NDI (AUC=0.75) and NRS-AP (AUC=0.74) were valid discriminators of meaningful improvement. Numeric rating scale for neck pain (AUC=0.69) was a poor discriminator. Neck disability index was also most responsive to postoperative improvement (SRM difference 0.78), followed by NRS-AP (SRM difference 0.59) and NRS-NP (SRM difference 0.46). For general health and quality of life, SF-12 PCS (AUC=0.79) was the only valid discriminator of meaningful improvement. Euro-Qol-5D (AUC=0.68) and SF-12 MCS (AUC=0.44) were poor discriminators. Short-form 12 physical component summary (SRM difference 1.08) was also most responsive compared with EQ-5D (SRM difference 0.89) and SF-12 MCS (SRM difference 0.01). Conclusions For pain and disability, NDI is the most valid and responsive measure of improvement after surgery for neck and arm pain. Numeric rating scale for neck pain and NRS-AP are poor substitutes for NDI when measuring effectiveness of care in registry efforts. For health-related quality of life, only SF-12 PCS could accurately discriminate meaningful improvement after cervical surgery and was found to be most valid and responsive. Large-scale registry efforts aimed at measuring effectiveness of cervical spine surgery should use NDI and SF-12 to accurately assess improvements in pain, disability, and quality of life.
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