To standardize outcome reporting in clinical trials of patients with nonspecific low back pain, an international multidisciplinary panel recommended physical functioning, pain intensity, and ...health-related quality of life (HRQoL) as core outcome domains. Given the lack of a consensus on measurement instruments for these 3 domains in patients with low back pain, this study aimed to generate such consensus. The measurement properties of 17 patient-reported outcome measures for physical functioning, 3 for pain intensity, and 5 for HRQoL were appraised in 3 systematic reviews following the COSMIN methodology. Researchers, clinicians, and patients (n = 207) were invited in a 2-round Delphi survey to generate consensus (≥67% agreement among participants) on which instruments to endorse. Response rates were 44% and 41%, respectively. In round 1, consensus was achieved on the Oswestry Disability Index version 2.1a for physical functioning (78% agreement) and the Numeric Rating Scale (NRS) for pain intensity (75% agreement). No consensus was achieved on any HRQoL instrument, although the Short Form 12 (SF12) approached the consensus threshold (64% agreement). In round 2, a consensus was reached on an NRS version with a 1-week recall period (96% agreement). Various participants requested 1 free-to-use instrument per domain. Considering all issues together, recommendations on core instruments were formulated: Oswestry Disability Index version 2.1a or 24-item Roland-Morris Disability Questionnaire for physical functioning, NRS for pain intensity, and SF12 or 10-item PROMIS Global Health form for HRQoL. Further studies need to fill the evidence gaps on the measurement properties of these and other instruments.
Purpose
Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core ...outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
Methods
An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
Results
A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45 %. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Consensus on ‘physical functioning’ and ‘pain intensity’ was consistent across all stakeholders, ‘health-related quality of life’ was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain ‘number of deaths’.
Conclusions
The following outcome domains were included in this updated COS: ‘physical functioning’, ‘pain intensity’, ‘health-related quality of life’ and ‘number of deaths’. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
We are developing a transmission-based probe for point-of-care assessment of vertebrae strength needed for fabricating the instrumentation used in supporting the spinal column during spinal fusion ...surgery. The device is based on a transmission probe whereby thin coaxial probes are inserted into the small canals through the pedicles and into the vertebrae, and a broad band signal is transmitted from one probe to the other across the bone tissue. Simultaneously, a machine vision scheme has been developed to measure the separation distance between the probe tips while they are inserted into the vertebrae. The latter technique includes a small camera mounted to the handle of one probe and associated fiducials printed on the other. Machine vision techniques make it possible to track the location of the fiducial-based probe tip and compare it to the fixed coordinate location of the camera-based probe tip. The combination of the two methods allows for straightforward calculation of tissue characteristics by exploiting the antenna far field approximation. Validation tests of the two concepts are presented as a precursor to clinical prototype development.
Abstract Background context Choosing appropriate surgical patients in the setting of spinal metastases can be challenging. Existing scoring systems focus primarily on patient selection or operative ...techniques. These scores are limited in their capacity to predict postoperative survival. Purpose The aim was to model survival after spine surgery for metastastic disease. Study design This was a retrospective multicenter study. Patient sample All patients who had undergone surgery for the treatment of metastatic spinal disease at one of four tertiary care centers between 2007 and 2013 were included. Outcome measure The outcome measure was 1-year survival after surgery. Methods Demographic, medical, oncologic, surgical, and survival data were abstracted from medical records. The effect of predictor variables on survival was evaluated alone and in combination using stepwise logistic regression. Multivariable logistic regression was subsequently used to adjust for confounders. A predictive score was then developed and compared against that of the modified Bauer score alone in terms of prognosticating 1-year survival after surgery. Results In the time period under investigation, 318 patients underwent surgical intervention for metastastic disease involving the spine, with 307 having data available for analysis. The survival rate at 1 year was 48% (n=142), with a median survival of 10 months. In final adjusted analysis, preoperative modified Bauer score (odds ratio OR 3.00; 95% confidence interval CI 1.80–5.01; p<.001), ambulatory status (OR 2.47; 95% CI 1.48–4.14; p=.001), and serum albumin (OR 2.80; 95% CI 1.66–4.72; p<.001) were all independent predictors of 1-year survival. The most parsimonious model weighted the modified Bauer score with 2 points and intact ambulatory status and normal serum albumin level with 1 point each, with a ceiling score of 3. The final model using the predictive score was able to explain 74% of the variation in 1-year survival. In contrast, the modified Bauer score alone was only able to explain 64% of the variation in 1-year survival. Conclusions This study demonstrates the importance of including factors related to the overall health of a patient, in addition to parameters surrounding their cancer diagnosis, to better prognosticate survival. Our predictive score performed better than the modified Bauer alone and may be used to predict survival after surgical intervention for metastatic disease. Level of evidence III.
This study was a post-hoc subgroup analysis of prospectively collected data in the Spine Patient Outcomes Research Trial (SPORT).
The aim of this study was to determine the risk factors for and to ...compare the outcomes of patients undergoing revision disc excision surgery in SPORT.
Risk factors for reherniation and outcomes after revision surgery have not been well-studied. This information is critical for proper patient counseling and decision-making.
Patients who underwent primary discectomy in the SPORT intervertebral disc herniation cohort were analyzed to determine risk factors for undergoing revision surgery. Risk factors for undergoing revision surgery for reherniation were evaluated using univariate and multivariate analysis. Primary outcome measures consisted of Oswestry Disability Index (ODI), the Sciatica Bothersomeness index (SBI), and the Short Form 36 (SF-36) at 6 weeks, 3 months, 6 months, and yearly to 4 years.
Of 810 surgical patients, 74 (9.1%) received revision surgery for reherniation. Risk factors for reherniation included: younger age (hazard ratio HR 0.96 0.94-0.99), lack of a sensory deficit (HR 0.61 0.37-0.99) lack of motor deficit (HR 0.54 0.32-0.91), and higher baseline ODI score (HR 1.02 1.01-1.03). The time-adjusted mean improvement from baseline to 4 years was less for the reherniation group on all outcome measures (Bodily Pain Index BP 39.5 vs. 44.9, P = 0.001; Physical Function Index PF 37.1 vs. 44.5, P < 0.001; ODI 33.9 vs. 38.3, P < 0.001; SBI 8.7 vs. 10.5, P < 0.001). At 4 years, only SBI (-9 vs. -11.4, P = 0.002) was significantly lower in the reherniation group.
Younger patients with higher baseline disability without neurological deficit are at increased risk of undergoing revision surgery for reherniation. Those considering revision surgery for reherniation will likely improve significantly following surgery, but possibly not as much as with primary discectomy.
3.
Cervical 2 (C2) fractures in the elderly are common, and the incidence of these fractures has been increasing. Surgical and nonoperative treatments are associated with high complication and mortality ...rates, and these rates have not been evaluated at the population level, to our knowledge. The purpose of this study was to use the Medicare claims database to determine trends in treatment, surgical and nonoperative outcomes, and Medicare reimbursement for treatment of these fractures.
We examined the Medicare claims database from 2000 to 2011 to identify patients admitted for the treatment of a C2 fracture. The incidence of fractures and the rates of nonoperative and surgical treatment were determined across the study period. We compared rates of mortality and life-threatening complications between patients treated nonoperatively and surgically. Centers for Medicare & Medicaid Services (CMS) payments for the initial admission as well as for subsequent inpatient admissions during the ninety-day post-admission period were compared between treatment groups. We used multivariate analysis to control for differences in patient characteristics between groups.
There were 81,596 admissions for C2 fracture identified, and 53,338 met inclusion criteria. The incidence of C2 fractures increased 135% from 2000 to 2011, but the rate of surgical treatment remained constant at 16%. There was significantly lower mortality at thirty days for the surgical group at 8.3% compared with the nonoperative group at 16.2% (p < 0.001) and at one year for the surgical group at 21.7% compared with the nonoperative group at 32.3% (p < 0.001). Life-threatening complications within thirty days of admission were slightly more common in the surgical group at 10.9% compared with the nonoperative group at 9.0% (p < 0.05). Medicare reimbursements for the initial inpatient admission were significantly higher (p < 0.001) in U.S. dollars for the surgical group at $21,487 compared with the nonoperative group at $8469, and this significant difference (p < 0.001) persisted in the ninety-day post-discharge period at $10,487 for the surgical group compared with $8410 for the nonoperative group.
Although the incidence of C2 fractures in the Medicare population increased from 2000 to 2011, the rate of surgery stayed relatively constant. After controlling for baseline differences, patients treated with surgery had significantly lower thirty-day and one-year mortality rates compared with patients treated nonoperatively.
Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
Outcome expectancies have been found to be predictive of substance use. While development of expectancies may be dynamic during adolescence, it is unknown whether the rate of change (slope) in ...substance use expectancies is a risk factor for use onset across multiple substance use domains. The present study tested the hypothesis that the slope of positive and negative alcohol, tobacco, and marijuana use expectancies during mid-adolescence (9th-10th grade) would predict use onset of each respective substance during late adolescence (11th-12th grade). Data from 3,396 ethnically diverse high school students were collected across eight waves of assessment and analyzed within a latent growth modeling framework. Results revealed that the slopes of positive substance use expectancies among never-users of each respective substance predicted increased odds of onset (Alcohol: ORB = 7.73, p < .001; Tobacco: ORB = 5.58, p < .001; Marijuana: ORB = 2.49, p = .001). Only the slope of negative marijuana expectancies predicted increased odds of onset (Marijuana: ORB = .44, p = .04). Baseline level of positive and negative substance use outcome expectancies were also generally found to be associated with onset. For three common drugs used by adolescents, change in substance use expectancies during the first two years of high school may be a marker of risk propensity for substance use onset. Change in expectancies may be an important target in substance use prevention, with research indicating that expectancy challenge and life skills interventions being potentially efficacious.
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