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1.
Susana Núñez-Pereira Alba Vila-Casademunt Montse Domingo-Sàbat Juan Bagó Emre R. Acaroglu Ahmet Alanay Ibrahim Obeid Francisco Javier Sánchez Pérez-Grueso Frank Kleinstück Ferran Pellisé 《The spine journal》2018,18(6):926-934
Background Context
Revision surgery represents a major event for patients undergoing adult spinal deformity (ASD) surgery. Previous reports suggest that ASD surgery has minimal or no impact on health-related-quality of life (HRQOL) outcomes.Purpose
The present study aims to investigate the impact of early reoperations within the first year on HRQOL and on the likelihood of reaching the minimally clinically important difference (MCID) after ASD surgery.Design
This is a retrospective analysis of prospectively collected data from consecutive surgically treated adult deformity surgery patients included in a multicenter, international database.Patient Sample
The present study included 280 patients from a multicenter international prospective database.Outcome Measure
Oswestry Disability Index (ODI), Short Form-36 (SF-36), Scoliosis Research Society-22 (SRS-22), MCID were evaluated in this work.Methods
Consecutive surgical patients with ASD recruited prospectively in six different centers from four countries with a minimum 2-year follow-up were stratified into two groups: R (revision surgery within the first year) and NR (no revision). Health-related-quality of life (ODI, SF-36, SRS-22) was assessed and compared at 6-month, 1-year, and 2-year follow-up stages. Statistical analysis included chi-square tests, Student t tests, and linear mixed models.Results
Forty-three patients (R Group) received 46 revision surgeries. Nineteen patients (41.3%) had implant-related complications, 9 patients (19.6%) had deep surgical site infections, 9 patients (19.6%) had proximal junctional kyphosis, 3 patients (6.5%) had hematoma, and 6 patients (13%) had other complications. Baseline characteristics differed between groups.At 6 months, all HRQOL scores improved in both groups, except in the SF-36 Mental Component Summary and SRS-22 mental health domain in the R Group. At 1 year, ODI and SRS-22 improvement was significantly greater in the NR Group, exceeding the reported MCID. At the 2-year follow-up, ODI, SRS-22, SF-36 MCS, and SF-36 PCS improvement was similar in both groups. However, postoperative change was only above the MCID for SF-36 PCS, ODI, and SRS-22 in the NR Group.Conclusions
Early unanticipated revision surgery has a negative impact on mental health at 6 months and reduces the chances of reaching an MCID improvement in SRS-22, SF-36 PCS, and ODI at the 2-year follow-up. 相似文献2.
Parker E. Bohm Michael G. Fehlings Branko Kopjar Lindsay A. Tetreault Alexander R. Vaccaro Karen K. Anderson Paul M. Arnold 《The spine journal》2017,17(2):211-217
Background Context
The timed 30-m walking test (30MWT) is used in clinical practice and in research to objectively quantify gait impairment. The psychometric properties of 30MWT have not yet been rigorously evaluated.Purpose
This study aimed to determine test-retest reliability, divergent and convergent validity, and responsiveness to change of the 30MWT in patients with degenerative cervical myelopathy (DCM).Study Design/Setting
A retrospective observational study was carried out.Patient Sample
The sample consisted of patients with symptomatic DCM enrolled in the AOSpine North America or AOSpine International cervical spondylotic myelopathy studies at 26 sites.Outcome Measures
Modified Japanese Orthopaedic Association scale (mJOA), Nurick scale, 30MWT, Neck Disability Index (NDI), and Short-Form-36 (SF-36v2) physical component score (PCS) and mental component score (MCS) were the outcome measures.Methods
Data from two prospective multicenter cohort myelopathy studies were merged. Each patient was evaluated at baseline and 6 months postoperatively.Results
Of 757 total patients, 682 (90.09%) attempted to perform the 30MWT at baseline. Of these 682 patients, 602 (88.12%) performed the 30MWT at baseline. One patient was excluded, leaving601 in the analysis. At baseline, 81 of 682 (11.88%) patients were unable to perform the test, and their mJOA, NDI, and SF-36v2 PCS scores were lower compared with those who performed the test at baseline. In patients who performed the 30MWT at baseline, there was very high correlation among the three baseline 30MWT measurements (r=0.9569–0.9919). The 30MWT demonstrated good convergent and divergent validity. It was moderately correlated with the Nurick (r=0.4932), mJOA (r=?0.4424), and SF-36v2 PCS (r=?0.3537) (convergent validity) and poorly correlated with the NDI (r=0.2107) and SF-36v2 MCS (r=?0.1984) (divergent validity). Overall, the 30MWT was not responsive to change (standardized response mean [SRM]=0.30). However, for patients who had a baseline time above the median value of 29 seconds, the SRM was 0.45.Conclusions
The 30MWT shows high test-retest reliability and good divergent and convergent validity. It is responsive to change only in patients with more severe myelopathy. The 30MWT is a simple, quick, and affordable test, and should be used as an ancillary test to evaluate gait parameters in patients with DCM. 相似文献3.
Michael G. Fehlings Branko Kopjar Ahmed Ibrahim Lindsay A. Tetreault Paul M. Arnold Helton Defino Shashank Sharad Kale S. Tim Yoon Giuseppe M. Barbagallo Ronald H.M. Bartels Qiang Zhou Alexander R. Vaccaro Mehmet Zileli Gamaliel Tan Yasutsugu Yukawa Darrel S. Brodke Christopher I. Shaffrey Osmar Santos de Moraes Mark B. Dekutoski 《The spine journal》2018,18(4):593-605
Background Context
Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness.Purpose
The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions.Study Design/Setting
This is a multicenter international prospective cohort study.Patient Sample
This study includes a total of 757 symptomatic patients with DCM undergoing surgical decompression of the cervical spine.Outcome Measures
The outcome measures are the Neck Disability Index (NDI), the Short Form 36 version 2 (SF-36v2), the modified Japanese Orthopaedic Association (mJOA) scale, and the Nurick grade.Materials and Methods
The baseline characteristics, disease causation, surgical approaches, and outcomes at 12 and 24 months were compared among four regions: Europe, Asia Pacific, Latin America, and North America.Results
Patients from Europe and North America were, on average, older than those from Latin America and Asia Pacific (p=.0055). Patients from Latin America had a significantly longer duration of symptoms than those from the other three regions (p<.0001). The most frequent causes of myelopathy were spondylosis and disc herniation. Ossification of the posterior longitudinal ligament was most prevalent in Asia Pacific (35.33%) and in Europe (31.75%), and hypertrophy of the ligamentum flavum was most prevalent in Latin America (61.25%). Surgical approaches varied by region; the majority of cases in Europe (71.43%), Asia Pacific (60.67%), and North America (59.10%) were managed anteriorly, whereas the posterior approach was more common in Latin America (66.25%). At the 24-month follow-up, patients from North America and Asia Pacific exhibited greater improvements in mJOA and Nurick scores than those from Europe and Latin America. Patients from Asia Pacific and Latin America demonstrated the most improvement on the NDI and SF-36v2 PCS. The longest duration of hospital stay was in Asia Pacific (14.16 days), and the highest rate of complications (34.9%) was reported in Europe.Conclusions
Regional differences in demographics, causation, and surgical approaches are significant for patients with DCM. Despite these variations, surgical decompression for DCM appears effective in all regions. Observed differences in the extent of postoperative improvements among the regions should encourage the standardization of care across centers and the development of international guidelines for the management of DCM. 相似文献4.
Maria M. Wertli Ulrike Held Angela Lis Marco Campello Sherri Weiser 《The spine journal》2018,18(8):1463-1474
Background Context
Negative beliefs are known to influence treatment outcome in patients with spine pain (SP). The impact of positive beliefs is less clear.Purpose
We aimed to assess the influence of positive and negative beliefs on baseline and treatment responses in patients with SP.Study Design/Setting
A retrospective cross-sectional and longitudinal analysis of prospectively collected data of outpatient physical therapy patients with SP was carried out. Questionnaires administered before and during treatment included the STarT Back distress scale (negative beliefs), and expectation and self-efficacy questions (positive beliefs).Patient Sample
Patients with SP with a baseline assessment and follow-up assessment comprised the study sample.Outcome Measure
Perceived disability was measured using the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI). A clinical meaningful change (minimum clinically important difference [MCID]) was defined as decrease in ODI or NDI of ≥30%.Methods
We used the Akaike Information Criterion from the first imputed dataset of the prediction model to select predictor variables. Prediction models were fitted to the outcome variables.Results
In the cross-sectional analysis, 1,695 low back pain (LBP) episodes and 487 neck pain (NP) episodes were analyzed. STarT Back Screening Tool (SBST)-distress was positively associated with perceived disability in both LBP (beta 2.31, 95% confidence interval [CI] 1.75–2.88) and NP (beta 2.57, 95% CI 1.47–3.67). Lower self-efficacy was negatively associated with more perceived disability for LBP (beta 0.50, 95% CI 0.29–0.72) but not for NP, whereas less positive expectations was associated with more perceived disability in NP (beta 0.57, 95% CI 0.02–1.12) but not in LBP. In the longitudinal analysis, 607 LBP episodes (36%) and 176 (36%) NP episodes were included. SBST-distress did not predict treatment outcome in spine patients. In LBP, patients with a lower positive expectation were less likely to experience an MCID in perceived disability (odds ratio [OR] per point increase 0.89, 95% CI 0.83–0.96), and there was a similar trend in NP (OR per point increase 0.90, 95% CI 0.79–1.03). In patients with LBP, lower self-efficacy at baseline was associated with a higher likelihood that an MCID was achieved (OR per point increase 1.09, 95% CI 1.01–1.19). In NP, self-efficacy was not included in the final model.Conclusions
Our study demonstrates that both negative and positive beliefs are associated with perceptions of disability. However, in this study, only positive beliefs were associated with treatment outcome. 相似文献5.
Michael G. Fehlings Carlo Santaguida Lindsay Tetreault Paul Arnold Giuseppe Barbagallo Helton Defino Shashank Kale Qiang Zhou Tim S. Yoon Branko Kopjar 《The spine journal》2017,17(1):102-108
Background Context
It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM).Purpose
The objective of this study is to compare outcomes of LP and LF.Study Design/Setting
This is a multicenter international prospective cohort study.Patient Sample
A total of 266 surgically treated symptomatic DCM patients undergoing cervical decompression using LP (N=100) or LF (N=166) were included.Outcome Measures
The outcome measures were the modified Japanese Orthopaedic Association score (mJOA), Nurick grade, Neck Disability Index (NDI), Short-Form 36v2 (SF36v2), length of hospital stay, length of stay in the intensive care unit, treatment complications, and reoperations.Methods
Differences in outcomes between the LP and LF groups were analyzed by analysis of variance and analysis of covariance. The dependent variable in all analyses was the change score between baseline and 24-month follow-up, and the independent variable was surgical procedure (LP or LF). In the analysis of covariance, outcomes were compared between cohorts while adjusting for gender, age, smoking, number of operative levels, duration of symptoms, geographic region, and baseline scores.Results
There were no differences in age, gender, smoking status, number of operated levels, and baseline Nurick, NDI, and SF36v2 scores between the LP and LF groups. Preoperative mJOA was lower in the LP compared with the LF group (11.52±2.77 and 12.30±2.85, respectively, p=.0297). Patients in both groups showed significant improvements in mJOA, Nurick grade, NDI, and SF36v2 physical and mental health component scores 24 months after surgery (p<.0001). At 24 months, mJOA scores improved by 3.49 (95% confidence interval [CI]: 2.84, 4.13) in the LP group compared with 2.39 (95% CI: 1.91, 2.86) in the LF group (p=.0069). Nurick grades improved by 1.57 (95% CI: 1.23, 1.90) in the LP group and 1.18 (95% CI: 0.92, 1.44) in the LF group (p=.0770). There were no differences between the groups with respect to NDI and SF36v2 outcomes. After adjustment for preoperative characteristics, surgical factors and geographic region, the differences in mJOA between surgical groups were no longer significant. The rate of treatment-related complications in the LF group was 28.31% compared with 21.00% in the LP group (p=.1079).Conclusions
Both LP and LF are effective at improving clinical disease severity, functional status, and quality of life in patients with DCM. In an unadjusted analysis, patients treated with LP achieved greater improvements on the mJOA at 24-month follow-up than those who received LF; however, these differences were insignificant following adjustment for relevant confounders. 相似文献6.
Ronald H.M.A. Bartels Roland D. Donk Wim I.M. Verhagen Allard J.F. Hosman André L.M. Verbeek 《The spine journal》2017,17(11):1625-1632
Background Context
The results of meta-analyses are frequently reported, but understanding and interpreting them is difficult for both clinicians and patients. Statistical significances are presented without referring to values that imply clinical relevance.Purpose
This study aimed to use the minimal clinically important difference (MCID) to rate the clinical relevance of a meta-analysis.Study Design
This study is a review of the literature.Patient Sample
This study is a review of meta-analyses relating to a specific topic, clinical results of cervical arthroplasty.Outcome Measure
The outcome measure used in the study was the MCID.Methods
We performed an extensive literature search of a series of meta-analyses evaluating a similar subject as an example. We searched in Pubmed and Embase through August 9, 2016, and found articles concerning meta-analyses of the clinical outcome of cervical arthroplasty compared with that of anterior cervical discectomy with fusion in cases of cervical degenerative disease. We evaluated the analyses for statistical significance and their relation to MCID. MCID was defined based on results in similar patient groups and a similar disease entity reported in the literature.Results
We identified 21 meta-analyses, only one of which referred to MCID. However, the researchers used an inappropriate measurement scale and, therefore, an incorrect MCID. The majority of the conclusions were based on statistical results without mentioning clinical relevance.Conclusions
The majority of the articles we reviewed drew conclusions based on statistical differences instead of clinical relevance. We recommend introducing the concept of MCID while reporting the results of a meta-analysis, as well as mentioning the explicit scale of the analyzed measurement. 相似文献7.
Johnny J. Wei Silky Chotai Ahilan Sivaganesan Kristin R. Archer Byron J. Schneider Aaron J. Yang Clinton J. Devin 《The spine journal》2018,18(5):788-796
Background Context
Chronic opioid therapy is associated with worse patient-reported outcomes (PROs) following spine surgery. However, little literature exists on the relationship between opioid use and PROs following epidural steroid injections for radicular pain.Purpose
We evaluated the association between pre-injection opioid use and PROs following spine epidural steroid injection.Study Design
This study is a retrospective analysis of a prospective longitudinal registry database.Patient Sample
A total of 392 patients within our database who were undergoing epidural steroid injections (ESIs) at our institution for degenerative structural spine diagnoses and met our inclusion criteria were included in this study.Outcome Measures
Patient-reported outcomes for disability (Oswestry Disability Index/Neck Disability Index [ODI/NDI)]), quality of life (EuroQol-5D [EQ-5D]), and pain (Numerical Rating Scale scores for back pain, neck pain, leg pain, and arm pain [NRS-BP/NP/LP/AP]) were assessed at baseline and at 3 and 12 months post-injection.Methods
Multivariable proportional odds logistic regression models were created to examine the relationship between pre-injection opioid use and post-injection PROs. A logistic regression with Bayesian Markov chain Monte Carlo parameter estimation was used to investigate a possible cutoff value of pre-injection opioid use above which the effectiveness of ESI (as measured by minimum clinically important difference [MCID] for ODI/NDI) decreases.Results
A total of 276 patients with complete 12-month follow-up following ESI were analyzed. The mean pre-injection daily morphine equivalent amount (MEA) was 14.7?mg (95% confidence interval [CI] 12.4?mg–19.1?mg) for the cohort. Pre-injection opioid use was associated with slightly higher odds of worse disability (odds ratio [OR] 1.03, p=.03) and leg/arm pain (OR 1.01, p=.04) scores at 3 months post-injection only. No significant association between pre-injection opioid use and MCID for ODI/NDI was found, although a cutoff of 55.5?mg/day might serve as a significant threshold.Conclusion
Increased pre-injection opioid use does not impact long-term outcomes after ESIs for degenerative spine diseases. A pre-injection MEA around 50?mg/day may represent a threshold above which the 3-month effectiveness of ESI for back- and neck-related disability decreases. Epidural steroid injection is an effective treatment modality for pain in patients using opioids, and can be part of a multimodal strategy for opioid independence. 相似文献8.
Vincent J. Alentado Stephanie Caldwell Heath P. Gould Michael P. Steinmetz Edward C. Benzel Thomas E. Mroz 《The spine journal》2017,17(2):236-243
Background Context
Multiple studies have determined minimum clinically important difference (MCID) thresholds for EuroQOL-5 Dimensions (EQ-5D) scores in lumbar fusion patients. However, a comprehensive understanding of predictors for a clinically significant improvement (CSI) postoperatively does not exist.Purpose
To determine medical, radiographic, and surgical predictors for obtaining a CSI following lumbar fusion surgery.Study Design
This is a retrospective review of patients who underwent instrumented lumbar fusion.Patient Sample
We included patients who underwent lumbar fusion for any indication between 2008 and 2013.Outcome Measures
Outcome measures included preoperative and postoperative EQ-5D Index scores.Materials and Methods
The medical records of patients who received a lumbar fusion for any indication were retrospectively reviewed to identify patient medical and surgical characteristics. A blinded reviewer assessed radiographs for each patient to examine sagittal alignment following fusion. Multivariable logistic regression was used to model the achievement of a CSI based on two commonly cited MCID values.Results
A total of 231 patients fit the inclusion criteria; 58% exceeded an MCID value for an EQ-5D score of 0.100, and 16% exceeded an MCID value of 0.390. Statistically significant independent predictors of not obtaining a CSI for an MCID threshold of 0.100 included a higher preoperative EQ-5D score (odds ratio [OR]=44.8) and L5-S1 fusion (OR=3.3). For an MCID value of 0.390, a higher preoperative EQ-5D score (OR=2,080.8) and a diagnosis of depression (OR=7.1) were predictive of not achieving a CSI, whereas spondylolisthesis (OR=4.1) was predictive of obtaining a CSI postoperatively. For both MCID values, patients who achieved a CSI had better postoperative quality of life (QOL) scores for all metrics measured, despite worse QOL scores preoperatively.Conclusions
This study is the first to use a combination of medical, surgical, and postoperative sagittal balance variables as determinants for the achievement of a CSI after lumbar fusion. The awareness of these predictors may allow for better patient selection and surgical approach to decrease the probability of acquiring a poor outcome postoperatively. 相似文献9.
Matthew F. Gornet Anne G. Copay Katrine M. Sorensen Francine W. Schranck 《The spine journal》2018,18(7):1292-1297
Background Context
Health-related quality-of-life outcomes have been collected with the Medical Outcomes Study (MOS) Short Form 36 (SF-36) survey. Boston University School of Public Health has developed algorithms for the conversion of SF-36 to Veterans RAND 12-Item Health Survey (VR-12) Physical Component Summary (PCS) and Mental Component Summary (MCS) scores.Purpose
The purpose of the present study is to investigate the conversion of the SF-36 to VR-12 PCS and MCS scores.Study Design
Preoperative and postoperative SF-36 were collected from patients who underwent lumbar or cervical surgery from a single surgeon between August 1998 and January 2013.Methods
Short Form 36 PCS and MCS scores were calculated following their original instructions. The SF-36 answers were then converted to VR-12 PCS and MCS scores following the algorithm provided by the Boston University School of Public Health. The mean score, preoperative to postoperative change, and proportions of patients who reach the minimum detectable change were compared between SF-36 and VR-12.Results
A total of 1,968 patients (1,559 lumbar and 409 cervical) had completed preoperative and postoperative SF-36. The values of the SF-36 and VR-12 mean scores were extremely similar, with score differences ranging from 0.77 to 1.82. The preoperative to postoperative improvement was highly significant (p<.001) for both SF-36 and VR-12 scores. The mean change scores were similar, with a difference of up to 0.93 for PCS and up to 0.37 for MCS. Minimum detectable change (MDC) values were almost identical for SF-36 and VR-12, with a difference of 0.12 for PCS and up to 0.41 for MCS. The proportions of patients whose change in score reached MDC were also nearly identical for SF-36 and VR-12. About 90% of the patients above SF-36 MDC were also above VR-12 MDC.Conclusions
The converted VR-12 scores, similar to the SF-36 scores, detect a significant postoperative improvement in PCS and MCS scores. The calculated MDC values and the proportions of patients whose score improvement reach MDC are similar for both SF-36 and VR-12. 相似文献10.
Christopher D. Witiw Lindsay A. Tetreault Fabrice Smieliauskas Branko Kopjar Eric M. Massicotte Michael G. Fehlings 《The spine journal》2017,17(1):15-25
Background Context
Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health-related quality of life outcomes and financial expenditures is needed to inform resource allocation decisions.Purpose
This study aimed to estimate the lifetime incremental cost-utility of surgical treatment for DCM.Design/Setting
This is a prospective observational cohort study at a Canadian tertiary care facility.Patient Sample
We recruited all patients undergoing surgery for DCM at a single center between 2005 and 2011 who were enrolled in either the AOSpine Cervical Spondylotic Myelopathy (CSM)-North America study or the AOSpine CSM-International study.Outcome Measures
Health utility was measured at baseline and at 6, 12, and 24 months following surgery using the Short Form-6D (SF-6D) health utility score. Resource expenditures were calculated on an individual level, from the hospital payer perspective over the 24-month follow-up period. All costs were obtained from a micro-cost database maintained by the institutional finance department and reported in Canadian dollars, inflated to January 2015 values.Methods
Quality-adjusted life year (QALY) gains for the study period were determined using an area under the curve calculation with a linear interpolation estimate. Lifetime incremental cost-to-utility ratios (ICUR) for surgery were estimated using a Markov state transition model. Structural uncertainty arising from lifetime extrapolation and the single-arm cohort design of the study were accounted for by constructing two models. The first included a highly conservative assumption that individuals undergoing nonoperative management would not experience any lifetime neurologic decline. This constraint was relaxed in the second model to permit more general parameters based on the established natural history. Deterministic and probabilistic sensitivity analyses were employed to account for parameter uncertainty. All QALY gains and costs were discounted at a base of 3% per annum. Statistical significance was set at the .05 level.Results
The analysis included 171 patients; follow-up was 96.5%. Mean age was 58.2±12.0 years and baseline health utility was 0.56±0.14. Mean QALY gained over the 24-month study period was 0.139 (95% confidence interval: 0.109–0.170, p<.001) and the mean 2-year cost of treatment was $19,217.82±12,404.23. Cost associated with the operation comprised 65.7% of the total. The remainder was apportioned over presurgical preparation and postsurgical recovery. Three patients required a reoperation over the 2-year follow-up period. The costs of revision surgery represented 1.85% of the total costs. Using the conservative model structure, the estimated lifetime ICUR of surgical intervention was $20,547.84/QALY gained, with 94.7% of estimates falling within the World Health Organization definition of “very cost-effective” ($54,000 CAD). Using the more general model structure, the estimated lifetime ICUR of surgical intervention was $11,496.02/QALY gained, with 97.9% of estimates meeting the criteria to be considered “very cost-effective.”Conclusions
Surgery for DCM is associated with a significant quality of life improvement. The intervention is cost-effective and, from the perspective of the hospital payer, should be supported. 相似文献11.
Minji K. Lee Kathleen J. Yost Jennifer S. McDonald Ryne W. Dougherty Roanna L. Vine David F. Kallmes 《The spine journal》2017,17(6):821-829
Background Context
The majority of validation done on the Roland-Morris Disability Questionnaire (RMDQ) has been in patients with mild or moderate disability. There is paucity of research focusing on the psychometric quality of the RMDQ in patients with severe disability.Purpose
To evaluate the psychometric quality of the RMDQ in patients with severe disability.Study Design/Setting
Observational clinical study.Sample
The sample consisted of 214 patients with painful vertebral compression fractures who underwent vertebroplasty or kyphoplasty.Outcome Measures
The 23-item version of the RMDQ was completed at two time points: baseline and 30-day postintervention follow-up.Methods
With the two-parameter logistic unidimensional item response theory (IRT) analyses, we derived the range of scores that produced reliable measurement and investigated the minimal clinically important difference (MCID).Results
Scores for 214 (100%) patients at baseline and 108 (50%) patients at follow-up did not meet the reliability criterion of 0.90 or higher, with the majority of patients having disability due to back pain that was too severe to be reliably measured by the RMDQ. Depending on methodology, MCID estimates ranged from 2 to 8 points and the proportion of patients classified as having experienced meaningful improvement ranged from 26% to 68%. A greater change in score was needed at the extreme ends of the score scale to be classified as having achieved MCID using IRT methods.Conclusions
Replacing items measuring moderate disability with items measuring severe disability could yield a version of the RMDQ that better targets patients with severe disability due to back pain. Improved precision in measuring disability would be valuable to clinicians who treat patients with greater functional impairments. Caution is needed when choosing criteria for interpreting meaningful change using the RMDQ. 相似文献12.
Background Context
Radiofrequency denervation is commonly used for the treatment of chronic facet joint pain that has been refractory to more conservative treatments, although the evidence supporting this treatment has been controversial.Purpose
We aimed to elucidate the precise effects of radiofrequency denervation in patients with low back pain originating from the facet joints relative to those obtained using control treatments, with particular attention to consistency in the denervation protocol.Study Design/Setting
A meta-analysis of randomized controlled trials was carried out.Patient Sample
Adult patients undergoing radiofrequency denervation or control treatments (sham or epidural block) for facet joint disease of the lumbar spine comprised the patient sample.Outcome Measures
Visual analog scale (VAS) pain scores were measured and stratified by response of diagnostic block procedures.Method
We searched PubMed, Embase, Web of Science, and the Cochrane Database for randomized controlled trials regarding radiofrequency denervation and control treatments for back pain. Changes in VAS pain scores of the radiofrequency group were compared with those of the control group as well as the minimal clinically important difference (MCID) for back pain VAS. Meta-regression model was developed to evaluate the effect of radiofrequency treatment according to responses of diagnostic block while controlling for other variables. We then calculated mean differences and 95% confidence intervals (CIs) using random-effects models.Results
We included data from seven trials involving 454 patients who had undergone radiofrequency denervation (231 patients) and control treatments such as sham or epidural block procedures (223 patients). The radiofrequency group exhibited significantly greater improvements in back pain score when compared with the control group for 1-year follow-up. Although the average improvement in VAS scores exceeded the MCID, the lower limit of the 95% CI encompassed the MCID. A subgroup of patients who responded very well to diagnostic block procedures demonstrated significant improvements in back pain relative to the control group at all times. When placed into our meta-regression model, the response to diagnostic block procedure was responsible for a statistically significant portion of treatment effect. Studies published over the last two decades revealed that radiofrequency denervation reduced back pain significantly in patients with facet joint disease compared with the MCID and control treatments.Conclusions
Conventional radiofrequency denervation resulted in significant reductions in low back pain originating from the facet joints in patients showing the best response to diagnostic block over the first 12 months when compared with sham procedures or epidural nerve blocks. 相似文献13.
Justin K. Scheer Malla Keefe Virginie Lafage Michael P. Kelly Shay Bess Douglas C. Burton Robert A. Hart Amit Jain Baron S. Lonner Themistocles S. Protopsaltis Richard Hostin Christopher I. Shaffrey Justin S. Smith Frank Schwab Christopher P. Ames 《The spine journal》2017,17(10):1397-1405
Background Context
Current metrics to assess patients' health-related quality of life (HRQOL) may not reflect a true change in the patients' specific perception of what is most important to them.Purpose
This study aimed to describe the initial experience of a Patient Generated Index (PGI) in which patients create their own outcome domains.Study Design
This is a single-center prospective study.Patient Sample
Patients with adult spinal deformity (ASD) comprise the study sample.Outcome Measures
Oswestry Disability Index (ODI), Short Form-36 (SF-36 Physical Component Score [PCS] and Mental Component Score [MCS]), Scoliosis Research Society-22r (SRS-22r), and PGI.Methods
Oswestry Disability Index, SF-36, SRS-22r, and PGI were administered preoperatively and postoperatively at 6 weeks, 3 months, 6 months, and 1 and 2 years. PGI correlations with ODI, SF-36, SRS total score, free-text frequency analysis of PGI exact response with text in ODI and SRS-22r questionnaires, and the responsiveness (effect size [ES]) of the HRQOL metrics were analyzed. No funding was used for this study and there are no conflicts of interest.Results
A total of 59 patients with 209 clinical encounters produced 370 PGI written response topics that included affect or emotions, relationships, activities of daily life, personal care, work, and hobbies. Mean preoperative PGI score was 18.6±13.5 (0–71.7 out of 100 [best]), and mean scores significantly improved at every postoperative time point (p<.05). Preoperative PGI scores significantly correlated with preoperative ODI (r=?0.28, p=.03), MCS (r=0.48, p<.01), and SRS total (r=0.57, p<.01). Postoperative PGI scores correlated with all HRQOL measures (p<.0001): ODI (r=?0.65), PCS (r=0.50), MCS (r=0.55), and SRS total (r=0.63). PGI responses exactly matched ODI and SRS-22r text at 47.8% and 35.4%, respectively, and at 63.2% and 58.9%, respectively, for categories. Patient Generated Index ES at a minimum of 1-year follow-up was ?2.39, indicating substantial responsiveness (|ES|>0.8). Effect sizes for ODI, SRS-22r total, SF-36 PCS, and SF-36 MCS were 2.16, ?2.06, ?2.05, and ?0.80, respectively.Conclusions
The PGI is easy to administer and offers additional information about the patients' perspective not captured in standard HRQOL metrics. Patient Generated Index scores correlated with all of the standard HRQOL scores and were more responsive than ODI, SF-36, and SRS-22r, suggesting that the PGI may be a step closer to one HRQOL measure that better encompasses concerns and goals of the individual patients. 相似文献14.
Shota Ikegami Jun Takahashi Hiromichi Misawa Takahiro Tsutsumimoto Mutsuki Yui Shugo Kuraishi Toshimasa Futatsugi Masashi Uehara Hiroki Oba Hiroyuki Kato 《The spine journal》2018,18(5):755-761
Background Context
There is little information on the relationship between magnetic resonance imaging (MRI) T2-weighted high signal change (T2HSC) in the spinal cord and surgical outcome for cervical myelopathy. We therefore examined whether T2HSC regression at 1 year postoperatively reflected a 5-year prognosis after adjustment using propensity scores for potential confounding variables, which have been a disadvantage of earlier observational studies.Purpose
The objective of this study was to clarify the usefulness of MRI signal changes for the prediction of midterm surgical outcome in patients with cervical myelopathy.Study Design/Setting
This is a retrospective cohort study.Patient Sample
We recruited 137 patients with cervical myelopathy who had undergone surgery between 2007 and 2012 at a median age of 69 years (range: 39–87 years).Outcome Measures
The outcome measures were the recovery rates of the Japanese Orthopaedic Association (JOA) scores and the visual analog scale (VAS) scores for complaints at several body regions.Materials and Methods
The subjects were divided according to the spinal MRI results at 1 year post surgery into the MRI regression group (Reg+ group, 37 cases) with fading of T2HSC, or the non-regression group (Reg? group, 100 cases) with either no change or an enlargement of T2HSC. The recovery rates of JOA scores from 1 to 5 years postoperatively along with the 5-year postoperative VAS scores were compared between the groups using t test. Outcome scores were adjusted for age, sex, diagnosis, symptom duration, and preoperative JOA score by the inverse probability weighting method using propensity scores.Results
The mean recovery rates in the Reg? group were 35.1%, 34.6%, 27.6%, 28.0%, and 30.1% from 1 to 5 years post surgery, respectively, whereas those in the Reg+ group were 52.0%, 52.0%, 51.1%, 49.0%, and 50.1%, respectively. The recovery rates in the Reg+ group were significantly higher at all observation points. At 5 years postoperatively, the VAS score for pain or numbnessin the arms or hands of the patients in the Reg+ group (24.7?mm) was significantly milder than that of the patients in the Reg? group (42.2?mm).Conclusions
Spinal T2HSC improvement at 1 year postoperatively may predict a favorable recovery until up to 5 years after surgery. 相似文献15.
Martin Skeppholm Roland Fransson Margareta Hammar Claes Olerud 《The spine journal》2017,17(6):790-798
Background Context
Previous research indicates that there might exist a link between the experience of pain and mental distress. Pain can possibly trigger anxiety and chronic pain, as well as also depression. On the other hand, anxiety and depression might also be risk factors for painful conditions and more pronounced subsequent disability and thus, the pathways may be bidirectional. Expanded knowledge of how different factors affect pain and function may help surgeons in preoperative decision-making.Purpose
The aim of this study was to evaluate the impact of potential preoperative risk factors with special reference to mental distress.Study Design/Setting
This is a prospective outcome study in a cohort from a multicenter randomized controlled trial comparing anterior cervical decompression and fusion with disc replacement.Patient Sample
The sample included 151 patients with cervical radiculopathy planned for surgery.Outcome Measures
Surgical outcome was evaluated with Neck Disability Index (NDI), health related quality-of-life with European Quality of Life-5 Dimensions, and pain with visual analogue scale for arm and neck. Mental distress was preoperatively measured with the Hospital Anxiety and Depression (HAD) scale.Methods
Preoperative data regarding possible risk factors for poor outcome were analyzed in multiple linear regression models with postoperative NDI and change of NDI as dependent factors. Patients with high preoperative levels of anxiety or depression (H-HAD), indicating mental distress, were compared with patients scoring low/moderate levels (L-HAD) regarding patient-reported outcome measures (PROMs) preoperatively and at 1- and 2-year follow-up.Results
Outcome data were available for 136 patients at the 2-year follow-up. No statistically significant difference in any outcome data could be demonstrated between the two surgical treatment groups. Mental distress was the variable most strongly associated with NDI at 2 years in the regression analysis. There were 42 patients classified as H-HAD and 94 as L-HAD. The average improvement in NDI was 16.9 in the H-HAD group and 26.3 in the L-HAD group, p=.02. The H-HAD patients showed a tendency for poorer baseline data and worse outcome overall in all PROMs at follow-up at both 1 and 2 years.Conclusions
Preoperative mental distress measured with HAD was associated with worse outcome overall. More research is needed to investigate whether patients with mental distress may achieve better results if other treatments are offered, either as non-surgical treatment alone or as an adjunct to surgery. 相似文献16.
Ahmad Fouad Abdelbaki Allam Tarek Abdalla Ahmed Abotakia Wael Koptan 《The spine journal》2018,18(7):1136-1142
Background Context
Cerebrolysin is a mixture containing 85% free amino acids and 15% biologically active low–molecular weight peptides that is believed to mimic the effects of endogenous neurotrophic factors to interact with the pathologic process cascade of neurodegenerative diseases. No study has examined the effect of Cerebrolysin on cervical myelopathic patients.Purpose
The objective of this study was to evaluate the effect of Cerebrolysin as a conservative modality on cervical spondylotic myelopathic patients.Study Design
This is a prospective randomized study.Patient Sample
A total of 192 patients with cervical spondylotic myelopathy (CSM) were subdivided blindly into two equal groups.Outcome Measures
Followed-up was performed at 1, 3, and 6 months comparing the recovery rate Japanese Orthopaedic Association (JOA) score for cervical myelopathy between the two groups.Methods
Group I received Cerebrolysin and Group II received placebo for 4 weeks; both groups received celecoxib 200?mg for 4 weeks.Results
Myelopathy improved in 92% and 52% of patients at 1 month in Groups I and II, respectively; these changed at 6 months to 87% and 33%; the remaining 13% in Group I neither improved nor deteriorated, whereas 60% in Group II neither improved nor deteriorated and 7% deteriorated with statistically significant differences when comparing the mean JOA recovery rate between the 2 groups at 1, 3, and 6 months.Conclusions
Cerebrolysin over 4 weeks is safe and effective for the improvement of CSM as compared with placebo, with no reported cases of neurologic deterioration over 6 months of follow-up. 相似文献17.
Jeffrey L. Gum Richard Hostin Chessie Robinson Michael P. Kelly Leah Yacat Carreon David W. Polly R. Shay Bess Douglas C. Burton Christopher I. Shaffrey Justin S. Smith Virginie LaFage Frank J. Schwab Christopher P. Ames Steven D. Glassman 《The spine journal》2017,17(1):96-101
Background Context
Over the past decade, the number of adult spinal deformity (ASD) surgeries has more than doubled in the United States. The complex surgeries needed to manage ASD are associated with significant resource utilization and high cost, making them a primary target for increased scrutiny. Accordingly, it is important to not only demonstrate value in ASD surgery as clinical effectiveness but also to translate outcome assessment to cost-effectiveness.Purpose
To compare the difference between Medicare allowable rates and the actual, direct hospital costs for ASD surgeries.Study Design
Longitudinal cohort.Patient Sample
Consecutive patients enrolled in an ASD database from a single institution.Outcome Measures
Short Form (SF)-6D.Methods
Consecutive patients enrolled in an ASD database from a single institution from 2008 to 2013 were identified. Direct hospital costs were collected from hospital administrative records for the entire inpatient episode of surgical care. Medicare allowable rates were calculated for the same inpatient stays using the year-appropriate Center for Medicare-Medicaid Services Inpatient Pricer Payment System Tool. The SF-6D, a utility index derived from the SF-36v1, was used to determine quality-adjusted life years (QALY). Costs and QALYs were discounted at 3.5% annually.Results
Of 580 surgical ASD patients eligible for 2-year follow up, 346 (60%) had complete baseline and 2-year data, and 60 were Medicare beneficiaries comprising the cohort for the present study. Mean SF-6D gained is 0.10 during year 1 after surgery and 0.02 at year 2, resulting in a cumulative SF-6D gain of 0.12 over 2 years. Mean Medicare allowable rate over the 2 years is $82,050 (range $42,383 to $220,749) and mean direct cost is $99,114 (range $28,447 to $217,717). Mean cost per QALY over 2 years is $683,750 using Medicare allowable rates and $825,950 using direct costs. This difference of $17,181 between the 2 cost calculation represents a 17% difference, which was statistically significant (p<.001).Conclusions
There is a significant difference in direct hospital costs versus Medicare allowable rates in ASD surgery and in turn, there is a similar difference in the cost per QALY calculation. Utilizing Medicare allowable rates not only underestimates (17%) the cost of ASD surgery, but it also creates inaccurate and unrealistic expectations for researchers and policymakers. 相似文献18.
Martin N. Stienen Nicolas R. Smoll Holger Joswig Jan Snagowski Marco V. Corniola Karl Schaller Gerhard Hildebrandt Oliver P. Gautschi 《The spine journal》2017,17(6):807-813
Background Context
The Timed Up and Go (TUG) test has recently been proposed as a simple and standardized measure for objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD).Purpose
The study aimed to explore the relationship between a patient's mental health status and both patient-reported outcome measures (PROMs) and TUG test results.Study Design/Setting
This is a prospective institutional review board-approved two-center study.Patient Sample
The sample was composed of 375 consecutive patients scheduled for lumbar spine surgery and a healthy cohort of 110 control subjects.Outcome Measures
Patients and control subjects were assessed with the TUG test and a comprehensive panel of subjective PROMs of pain intensity (visual analog scale [VAS]), functional impairment (Roland-Morris Disability Index [RMDI]), Oswestry Disability Index [ODI]), as well as health-related quality of life (hrQoL; Euro-Qol [EQ]-5D).Methods
Standardized age- and sex-adjusted TUG test T-scores were calculated. The dependent variable was the short-form (SF)-12 mental component summary (MCS) quartiles, and the independent variables were the TUG T-scores and PROMs. Direct and adjusted analyses of covariance were performed to estimate the interaction between the SF-12 MCS quartiles and the independent variables.Results
In patients, there was a significant decrease in the subjective PROMs, notably the VAS back pain (p=.001) and VAS leg pain (p=.035), as well as significant increase in the RMDI (p<.001), ODI (p<.001), and the EQ-5D index (p<.001) with every increase in the quartile of the SF-12 MCS. There were no significant group differences of OFI as measured by the TUG T-scores across the SF-12 MCS quartiles (p=.462). In the healthy control group, a significant decrease in VAS leg pain (p=.028), RMDI (p=.013), and ODI (p<.001), as well as a significant increase in the EQ-5D index (p<.001), was seen across the SF-12 MCS quartiles, whereas TUG T-scores remained stable (p=.897).Conclusions
There are significant influences of mental hrQoL on subjective measures of pain, functional impairment, and hrQoL that might lead to bias when evaluating patients with lumbar DDD who suffer from reduced mental hrQoL. The TUG test appears to be a stable instrument and especially helpful in the evaluation of patients with lumbar DDD and mental health problems. 相似文献19.
20.
Jae Hwan Cho Jae Hyup Lee Jin Sup Yeom Bong-Soon Chang Jae Jun Yang Ki Hyoung Koo Chang Ju Hwang Kwang Bok Lee Ho-Joong Kim Choon-Ki Lee Hyoungmin Kim Kyung-Soo Suk Woo Dong Nam Jumi Han 《The spine journal》2017,17(12):1866-1874