Systematic review.
To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP).
The treatment of CLBP has been associated with multiple clinical ...challenges. Further complicating this is the myriad of outcome scores used to assess treatment of CLBP. These scores have been used to examine different domains of patient satisfaction and quality of life in the literature. Critical assessment of the frequency, parity, and the quality of these outcomes are essential to improve our understanding of CLBP.
A systematic review of the English-language literature was undertaken for articles published from January 2001 through December 31, 2010. Electronic databases and reference lists of key articles were searched to identify measures used to evaluate outcomes in six different domains in patients with CLBP. The titles and abstracts of the peer-reviewed literature of LBP were searched to determine which of these measures were most commonly reported in the literature and which have been validated in populations with CLBP.
We identified 75 outcome measures cited to evaluate CLBP. Twenty-nine of these outcome measures were excluded because of only a single citation leaving 46 measures for the evaluation. The most commonly used functional outcomes were the Oswestry Disability Index, Roland Morris Disability Index, and range of motion. For pain, the Numeric Pain Rating Scale, Brief Pain Inventory, Pain Disability Index, McGill Pain Questionnaire, and visual analog scale were most commonly cited. For psychosocial function, the Fear Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Beck Depression Inventory were most commonly used. For generic quality of life, short form 36, Nottingham Health Profile, short form 12, and Sickness Impact Profile were the most common measures. For objective measures, the work status/return to work, complications or adverse events, and medications used were the most commonly cited. For preference-based measures, the Euro-Quol 5 dimensions and short form 6 dimensions were most commonly cited. The validity, reliability, responsiveness, universality, and potential proprietary requirements are summarized for each.
Outcome measures should be routinely assessed in patients with CLBP. The choice of appropriate outcome measure should be influenced by the study objectives and design, as well as properties of the particular measure within the context of CLBP.
Recommendation 1: When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. Other considerations include the number of items required (especially in the context of multiple measures), whether the measure is validated in the relevant language, and the associated costs or fees. Strength: Strong Recommendation 2: Domains of greatest importance include pain, function, and quality of life. If cost utilization is a priority, then preference-based measures should be considered. For pain, we recommend the VAS and NRPS because of their ease of administration and responsiveness. For function, we recommend the ODI and RMDQ. The SF-36 and its shorter versions are most commonly used and should be considered if quality of life is important. If cost utility is important, consider the EQ-5D or SF-6D. Psychosocial tests are best used as screening tools prior to surgery because of their lack of responsiveness. Complications should always be assessed as a standard of clinical practice. Return to work and medication use are complicated outcome measures and not recommended unless the specific study question is focused on these domains. Consider staff and patient burden when prioritizing one's battery of measures.
Abstract
Here, we systematically review clinical studies that report morbidity and outcomes data for cervical and lumbar surgeries performed in ambulatory surgery centers (ASCs). We focus on anterior ...cervical discectomy and fusion (ACDF), posterior cervical foraminotomy, cervical arthroplasty, lumbar microdiscectomy, lumbar laminectomy, and minimally invasive transforaminal interbody fusion (TLIF) and lateral lumbar interbody fusion, as these are prevalent and surgical spine procedures that are becoming more commonly performed in ASC settings.
A systematic search of PubMed was conducted, using combinations of the following phrases: “outpatient,” “ambulatory,” or “ASC” with “anterior cervical discectomy fusion,” “ACDF,” “cervical arthroplasty,” “lumbar,” “microdiscectomy,” “laminectomy,” “transforaminal lumbar interbody fusion,” “spine surgery,” or “TLIF.”
In reviewing the available literature to date, there is ample level 3 (retrospective comparisons) and level 4 (case series) evidence to support both the safety and effectiveness of outpatient cervical and lumbar surgery. While no level 1 or 2 (randomized clinical trials) evidence currently exists, the plethora of real-world clinical data creates a formidable argument for serious investments in ASCs for multiple spine procedures.
Abstract Multimodal approaches to pain management have arisen with the goal of improving postoperative pain and reducing opioid analgesic use. We performed a comprehensive literature review to ...determine grades of recommendation for commonly used agents in multimodal pain management and provide a best practice guideline. To evaluate common drugs used in multimodal treatment of pain, a search was performed on English language publications on Medline (PubMed; National Library of Medicine, Bethesda, MD, USA). Manuscripts were rated as Level I–V according to the North American Spine Society’s (NASS) standardized levels of evidence tables. Grades of recommendation were assigned for each drug based on the NASS Clinical Guidelines for Multidisciplinary Spine Care. There is good (Grade A) evidence gabapentinoids, acetaminophen, neuraxial blockade and extended-release local anesthetics reduce postoperative pain and narcotic requirements. There is fair (Grade B) evidence that preemptive analgesia and nonsteroidal anti-inflammatory drugs (NSAID) result in reduced postoperative pain. There is insufficient and/or conflicting (Grade I) evidence that muscle relaxants and ketamine provide a significant reduction in postoperative pain or narcotic usage. There is fair (Grade B) evidence that short-term use of NSAID result in no long-term reduction in bone healing or fusion rates. Comprehensive assessment of the effectiveness of perioperative pain control can be accomplished through the use of validated measures. Multimodal pain management protocols have consistently been demonstrated to allow for improved pain control with less reliance on opioids. There is good quality evidence that supports many of the common agents utilized in multimodal therapy, however, there is a lack of evidence regarding optimal postoperative protocols or pathways.
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.
Vertebral compression fractures are a prevalent disease affecting osteoporotic patients. When symptomatic, they cause significant pain and loss of function and have a high public health impact. In ...this paper we outline the diagnosis and management of these patients, with evidence-based review of treatment outcomes for the various therapeutic options. Diagnosis involves a clinical history focusing on the nature of the patient's pain as well as various imaging studies. Management is multimodal in nature and starts with conservative therapy consisting of analgesic medication, medication for osteoporosis, physical therapy, and bracing. Patients who are refractory to conservative management may be candidates for vertebral augmentation through either vertebroplasty or kyphoplasty.
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.
OBJECT Lumbar spine surgery has been demonstrated to be efficacious for many degenerative spine conditions. However, there is wide variability in outcome after spine surgery at the individual patient ...level. All stakeholders in spine care will benefit from identification of the unique patient or disease subgroups that are least likely to benefit from surgery, are prone to costly complications, and have increased health care utilization. There remains a large demand for individual patient-level predictive analytics to guide decision support to optimize outcomes at the patient and population levels. METHODS One thousand eight hundred three consecutive patients undergoing spine surgery for various degenerative lumbar diagnoses were prospectively enrolled and followed for 1 year. A comprehensive patient interview and health assessment was performed at baseline and at 3 and 12 months after surgery. All predictive covariates were selected a priori. Eighty percent of the sample was randomly selected for model development, and 20% for model validation. Linear regression was performed with Bayesian model averaging to model 12-month ODI (Oswestry Disability Index). Logistic regression with Bayesian model averaging was used to model likelihood of complications, 30-day readmission, need for inpatient rehabilitation, and return to work. Goodness-of-fit was assessed via R(2) for 12-month ODI and via the c-statistic, area under the receiver operating characteristic curve (AUC), for the categorical endpoints. Discrimination (predictive performance) was assessed, using R(2) for the ODI model and the c-statistic for the categorical endpoint models. Calibration was assessed using a plot of predicted versus observed values for the ODI model and the Hosmer-Lemeshow test for the categorical endpoint models. RESULTS On average, all patient-reported outcomes (PROs) were improved after surgery (ODI baseline vs 12 month: 50.4 vs 29.5%, p < 0.001). Complications occurred in 121 patients (6.6%), 108 (5.9%) were readmitted within 30 days of surgery, 188 (10.3%) required discharge to inpatient rehabilitation, 1630 (88.9%) returned to work, and 449 (24.5%) experienced an unplanned outcome (no improvement in ODI, a complication, or readmission). There were 45 unique baseline variable inputs, derived from 39 clinical variables and 38 questionnaire items (ODI, SF-12, MSPQ, VAS-BP, VAS-LP, VAS-NP), included in each model. For prediction of 12-month ODI, R(2) was 0.51 for development and 0.47 for the validation study. For prediction of a complication, readmission, inpatient rehabilitation, and return to work, AUC values ranged 0.72-0.84 for development and 0.79-0.84 for validation study. CONCLUSIONS A novel prediction model utilizing both clinical data and patient interview inputs explained the majority of variation in outcome observed after lumbar spine surgery and reliably predicted 12-month improvement in physical disability, return to work, major complications, readmission, and need for inpatient rehabilitation for individual patients. Application of these models may allow clinicians to offer spine surgery specifically to those who are most likely to benefit and least likely to incur complications and excess costs.
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.
Outcome studies for spine surgery rely on patient-reported outcomes (PROs) to assess treatment effects. Commonly used health-related quality-of-life questionnaires include the following scales: back ...pain and leg pain visual analog scale (BP-VAS and LP-VAS); the Oswestry Disability Index (ODI); and the EuroQol-5D health survey (EQ-5D). A shortcoming of these questionnaires is that their numerical scores lack a direct meaning or clinical significance. Because of this, the concept of the minimum clinically important difference (MCID) has been put forth as a measure for the critical threshold needed to achieve treatment effectiveness. By this measure, treatment effects reaching the MCID threshold value imply clinical significance and justification for implementation into clinical practice.
In 45 consecutive patients undergoing transforaminal lumbar interbody fusion (TLIF) for low-grade degenerative lumbar spondylolisthesis-associated back and leg pain, PRO questionnaires measuring BP-VAS, LPVAS, ODI, and EQ-5D were administered preoperatively and at 2 years postoperatively, and 2-year change scores were calculated. Four established anchor-based MCID calculation methods were used to calculate MCID, as follows: 1) average change; 2) minimum detectable change (MDC); 3) change difference; and 4) receiver operating characteristic curve analysis for two separate anchors (the health transition index HTI of the 36-Item Short Form Health Survey SF-36, and the satisfaction index).
All patients were available at the 2-year follow-up. The 2-year improvements in BP-VAS, LP-VAS, ODI, and EQ-5D scores were 4.3 ± 2.9, 3.8 ± 3.4, 19.5 ± 11.3, and 0.43 ± 0.44, respectively (mean ± SD). The 4 MCID calculation methods generated a range of MCID values for each of the PROs (BP-VAS, 2.1-5.3; LP-VAS, 2.1-4.7; ODI, 11-22.9; and EQ-5D, 0.15-0.54). The mean area under the curve (AUC) for the receiver operating characteristic curve from the 4 PRO-specific calculations was greater for the HTI versus satisfaction anchor (HTI AUC 0.73 vs satisfaction AUC 0.69), suggesting HTI as a more accurate anchor.
The TLIF-specific MCID is highly variable based on calculation technique. The MDC approach with the SF-36 HTI anchor appears to be most appropriate for calculating MCID because it provided a threshold above the 95% CI of the unimproved cohort (greater than the measurement error), was closest to the mean change score reported by improved and satisfied patients, and was least affected by the choice of anchor. Based on the MDC method with HTI anchor, MCID scores following TLIF are 2.1 points for BP-VAS, 2.8 points for LP-VAS, 14.9 points for ODI, and 0.46 quality-adjusted life years for EQ-5D.
Abstract Background context Despite improvements through the use of prophylactic systemic antibiotics, surgical site infections remain a significant problem in the treatment of traumatic spine ...injuries. Infection rates as high as 10% have been reported in this population. The impact on patients and cost of treating such infections is profound. Local delivery of antibiotics has been found to be efficacious in animal and human studies as an adjunct to systemic antibiotics in surgical site infection prophylaxis. Purpose To evaluate the efficacy of using vancomycin powder in surgical sites to prevent infections. Study design Retrospective case review. Patient sample Patients who underwent posterior spine fusions for traumatic injuries over a 2-year period at a single academic center. Outcome measures Clinical outcome determined was the incidence of either superficial or deep postoperative wound infections. Methods A retrospective review of 110 patients with traumatic spine injuries treated with instrumented posterior spine fusions over a 2-year period at a single academic center was performed. One group (control group) received standard systemic prophylaxis only, whereas another (treatment group) received vancomycin powder in the surgical wound in addition to systemic prophylaxis. Patient demographics and perioperative information obtained included history of previous spine surgeries, substance use, diabetes, body mass index, level of injury, presence of neurologic deficit, operative time, and estimated blood loss. Incidence of infection was the primary outcome evaluated. Results The control (N=54) and treatment groups (N=56) were statistically similar. A statistically significant difference in infection rate was found between the treatment group (0%) and control group (13%, p=.02) without any adverse events. No adverse effects were noted from use of the vancomycin powder. Conclusions The use of vancomycin powder in surgical wounds may significantly reduce the incidence of infection in patients with traumatic spine injuries treated with instrumented posterior spine fusion. Applying vancomycin powder to surgical wounds is a promising means of preventing costly and harmful postoperative wound infections in high-risk populations.
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