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1.

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   

2.

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   

3.

Background Context

Proper patient selection is of utmost importance in the surgical treatment of degenerative disc disease (DDD) with chronic low back pain (CLBP). Among other factors, gender was previously found to influence lumbar fusion surgery outcome.

Purpose

This study investigates whether gender affects clinical outcome after lumbar fusion.

Study Design

This is a national registry cohort study.

Patient sample

Between 2001 and 2011, 2,251 men and 2,521 women were followed prospectively within the Swedish National Spine Register (SWESPINE) after lumbar fusion surgery for DDD and CLBP.

Outcome measures

Patient-reported outcome measures (PROMs), visual analog scale (VAS) for leg and back pain, Oswestry Disability Index (ODI), quality of life (QoL) parameter EQ5D, and labor status and pain medication were collected preoperatively, 1 and 2 years after surgery.

Methods

Gender differences of baseline data and PROM improvement from baseline were analyzed. The effect of gender on clinically important improvement of PROM was determined in a multivariate logistic regression model. Furthermore, gender-related differences in return-to-work were investigated.

Results

Preoperatively, women had worse leg pain (p<.001), back pain (p=.002), lower QoL (p<.001), and greater disability than men (p=.001). Postoperatively, women presented greater improvement 2 years from baseline for pain, function, and QoL (all p<.01). Women had better chances of a clinically important improvement than men for leg pain (odds ratio [OR]=1.39, 95% confidence interval [CI]: 1.19–1.61, p<.01) and back pain (OR=1.20,95% CI:1.03–1.40, p=.02) as well as ODI (OR=1.24, 95% CI:1.05–1.47, p=.01), but improved at a slower pace in leg pain (p<.001), back pain (p=.009), and disability (p=.008). No gender differences were found in QoL and return to work at 2 years postoperatively.

Conclusions

Swedish women do not have worse results than men after spinal fusion surgery. Female patients present with worse pain and function preoperatively, but improve more than men do after surgery.  相似文献   

4.

Background Context

Lumbar fusion is a common and costly procedure in the United States. Reimbursement for surgical procedures is increasingly tied to care quality and patient safety as part of value-based reimbursement programs. The incidence of adverse quality events among lumbar fusion patients is unknown using the definition of care quality (patient safety indicators [PSI]) used by the Centers for Medicare and Medicaid Services (CMS). The association between insurance status and the incidence of PSI is similarly unknown in lumbar fusion patients.

Purpose

This study sought to determine the incidence of PSI in patients undergoing inpatient lumbar fusion and to quantify the association between primary payer status and PSI in this population.

Study Design

A retrospective cohort study was carried out.

Patient Sample

The sample comprised all adult patients aged 18 years and older who were included in the Nationwide Inpatient Sample (NIS) that underwent lumbar fusion from 1998 to 2011.

Outcome Measure

The incidence of one or more PSI, a validated and widely used metric of inpatient health-care quality and patient safety, was the primary outcome variable.

Methods

The NIS data were examined for all cases of inpatient lumbar fusion from 1998 to 2011. The incidence of adverse patient safety events (PSI) was determined using publicly available lists of the International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. Logistic regression models were used to determine the association between primary payer status (Medicaid and self-pay relative to private insurance) and the incidence of PSI.

Results

A total of 539,172 adult lumbar fusion procedures were recorded in the NIS from 1998 to 2011. Patients were excluded from the secondary analysis if “other” or “missing” was listed for primary insurance status. The national incidence of PSI was calculated to be 2,445 per 100,000 patient years of observation, or approximately 2.5%. In a secondary analysis, after adjusting for patient demographics and hospital characteristics, Medicaid and self-pay patients had significantly greater odds of experiencing one or more PSI during the inpatient episode relative to privately insured patients (odds ratio 1.16, 95% confidence interval 1.07–1.27).

Conclusions

Among patients undergoing inpatient lumbar fusion, insurance status is associated with the adverse health-care quality events used to determine hospital reimbursement by the CMS. The source of this disparity must be studied to improve the quality of care delivered to vulnerable patient populations.  相似文献   

5.

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   

6.

Background Context

There have been conflicting results on the surgical outcome of lumbar fusion surgery using two different techniques: robot-assisted pedicle screw fixation and conventional freehand technique. In addition, there have been no studies about the biomechanical issues between both techniques.

Purpose

This study aimed to investigate the biomechanical properties in terms of stress at adjacent segments using robot-assisted pedicle screw insertion technique (robot-assisted, minimally invasive posterior lumbar interbody fusion, Rom-PLIF) and freehand technique (conventional, freehand, open approach, posterior lumbar interbody fusion, Cop-PLIF) for instrumented lumbar fusion surgery.

Study Design

This is an additional post-hoc analysis for patient-specific finite element (FE) model.

Patient Sample

The sample is composed of patients with degenerative lumbar disease.

Outcome Measures

Intradiscal pressure and facet contact force are the outcome measures.

Methods

Patients were randomly assigned to undergo an instrumented PLIF procedure using a Rom-PLIF (37 patients) or a Cop-PLIF (41), respectively. Five patients in each group were selected using a simple random sampling method after operation, and 10 preoperative and postoperative lumbar spines were modeled from preoperative high-resolution computed tomography of 10 patients using the same method for a validated lumbar spine model. Under four pure moments of 7.5?Nm, the changes in intradiscal pressure and facet joint contact force at the proximal adjacent segment following fusion surgery were analyzed and compared with preoperative states.

Results

The representativeness of random samples was verified. Both groups showed significant increases in postoperative intradiscal pressure at the proximal adjacent segment under four moments, compared with the preoperative state. The Cop-PLIF models demonstrated significantly higher percent increments of intradiscal pressure at proximal adjacent segments under extension, lateral bending, and torsion moments than the Rom-PLIF models (p=.032, p=.008, and p=.016, respectively). Furthermore, the percent increment of facet contact force was significantly higher in the Cop-PLIF models under extension and torsion moments than in the Rom-PLIF models (p=.016 under both extension and torsion moments).

Conclusions

The present study showed the clinical application of subject-specific FE analysis in the spine. Even though there was biomechanical superiority of the robot-assisted insertions in terms of alleviation of stress increments at adjacent segments after fusion, cautious interpretation is needed because of the small sample size.  相似文献   

7.

Background Context

Laminectomy with posterior lumbar interbody fusion (PLIF) has been shown to achieve satisfactory clinical outcomes, but it leads to potential adverse consequences associated with extensive disruption of posterior bony and soft tissue structures.

Purpose

This study aimed to compare the clinical and radiographic outcomes of bilateral decompression via a unilateral approach (BDUA) with transforaminal lumbar interbody fusion (TLIF) and laminectomy with PLIF in the treatment of degenerative lumbar spondylolisthesis (DLS) with stenosis.

Study Design

This is a prospective cohort study.

Patient Sample

This study compared 43 patients undergoing BDUA+TLIF and 40 patients undergoing laminectomy+PLIF.

Outcome Measures

Visual analog scale (VAS) for low back pain and leg pain, Oswestry Disability Index (ODI), and Zurich Claudication Questionnaire (ZCQ) score.

Methods

The clinical outcomes were assessed, and intraoperative data and complications were collected. Radiographic outcomes included slippage of the vertebra, disc space height, segmental lordosis, and final fusion rate. This study was supported by a grant from The National Natural Science Foundation of China (81572168).

Results

There were significant improvements in clinical and radiographic outcomes from before surgery to 3 months and 2 years after surgery within each group. Analysis of leg pain VAS and ZCQ scores showed no significant differences in improvement between groups at either follow-up. The mean improvements in low back pain VAS and ODI scores were significantly greater in the BDUA+TLIF group than in the laminectomy+PLIF group. No significant difference was found in the final fusion rate at 2-year follow-up. The BDUA+TLIF group had significantly less blood loss, shorter length of postoperative hospital stay, and lower complication rate compared with the laminectomy+PLIF group.

Conclusions

When compared with the conventional laminectomy+PLIF procedure, the BDUA+TLIF procedure achieves similar and satisfactory effects of decompression and fusion for DLS with stenosis. The BDUA+TLIF procedure appears to be associated with less postoperative low back discomfort and quicker recovery.  相似文献   

8.

Background Context

Understanding the influence of preoperative diagnosis on outcomes for lumbar fusion surgery improves the quality of research and outcomes data, and helps guide treatment decisions.

Purpose

We sought to perform a systematic review of the literature published between 2000 and 2014 regarding lumbar fusion outcomes for degenerative disorders. An assessment of the influence of subgroup diagnosis on outcomes as well as the quality of this body of literature was performed.

Study Design

Systematic review

Patient Sample

The 100 studies ultimately included involved adult patients (n=8,706) undergoing fusion surgery for degenerative disorders of the lumbar spine.

Outcome Measures

Visual analog scale (VAS) pain scores, complication rates, and determination of successful fusion

Methods

With adherence to the PRISMA guidelines, electronic searches were performed through PubMed, Scopus, and Web of Science to identify all studies involving lumbar fusion for degenerative disc disorders from January 2000 to August 2014. Studies were eligible for inclusion if they addressed adult patients treated with lumbar fusion for one of the following: stable degenerative disc disease, unstable degenerative disc disease, degenerative disc disease not specified (DDDns), herniated disc (DH), degenerative spondylolisthesis (DDDsp), and adult degenerative scoliosis (DDDsc). Abstracted data included the number of patients, preoperative diagnosis, fusion technique, complications, fusion rate, and clinical outcomes.

Results

One hundred articles met inclusion criteria and yielded data for 8,706 patients. Forty-three studies included data for clinical improvement (VAS scores). The mean clinical improvement in VAS scores was significantly different among the diagnoses (p<.001), with DDDsp demonstrating the highest improvement (60%) and DDDns having the lowest (45%). Eighty-five studies included data for complication rates. Complication rates differed significantly (p<.001), with the highest rate seen in the DDDsc group (18%), followed by DDDsp (14%). Seventy-eight studies included data for fusion. The pooled odds of fusion for prospective studies were 6.93 (95% CI 4.75, 10.13). There was no evidence of publication bias.

Conclusions

A relationship between outcomes and subgroup diagnosis was demonstrated. This review demonstrated a higher quality of evidence in the literature, and greater overall fusion rates compared to similar studies published in the 1980s and 1990s.  相似文献   

9.

Background Context

Prior studies have suggested no significant differences in functional status and postoperative complications of elderly versus nonelderly patients undergoing posterior lumbar interbody fusion; however, similar studies have not been comprehensively investigated in the setting of anterior lumbar interbody fusion (ALIF).

Purpose

The objective was to quantify the ability of the modified Frailty Index (mFI) to predict postoperative events in patients undergoing ALIF.

Study Design

Secondary analysis of prospectively collected data.

Patient Sample

Patients undergoing ALIF in the National Surgical Quality Improvement Program (NSQIP) participant files for the period 2010 through 2014.

Outcomes Measures

Outcome measures included any postoperative complication, return to operating room (OR), and length of stay >5 days.

Methods

NSQIP participant files from 2010 to 2014 were used to identify patients undergoing ALIF. The mFI used in the present study is an 11-variable assessment that maps 16 NSQIP variables to 11 variables in the Canadian Study of Health and Ageing Frailty Index. Univariate analysis and multivariable logistic regression models were used to compare the relative strength of association between mFI with outcome variables of interest.

Results

In total, 3,920 ALIF cases were identified and grouped according to their mFI score: 0 (n=2,025), 0.09 (n=1,382), 0.18 (n=464), or ≥0.27 (n=49). As the mFI increased from 0 (no frailty-associated variables) to 0.27 (4 of 11) or higher, there was a significant stepwise increase in any complication from 10.8% to 32.7%. After multivariable regression analysis, no significant association was found between higher mFI scores with urinary tract infections and venous thromboembolism. High frailty scores were significant predictors of any complication (mFI of ≥0.27 [reference: 0]; OR 2.4; p=.040) and pulmonary complications (mFI score ≥0.27; OR 7.5; p=.001).

Conclusions

In summary, high mFI scores were found to be independently associated with any complication and pulmonary complications in patients who underwent ALIF. The use of mFI together with traditional risk factors may help better identify high-surgical risk patients, which may be useful for preoperative and postoperative care optimization.  相似文献   

10.

Background Context

Sagittal imbalance is associated with poor clinical outcomes in patients with degenerative lumbar disease. However, there is no consensus on the impact of posterior lumbar interbody fusion (PLIF) on local and global sagittal balance.

Purpose

To reveal the effect of one- or two-level PLIF on global sagittal balance.

Design/Setting

A retrospective case-control study.

Patients Sample

This study included 88 patients who underwent a one- or two-level PLIF for spinal stenosis with spondylolisthesis.

Outcome Measures

Clinical and radiological parameters were measured pre- and postoperatively.

Methods

All patients were followed up for >2 years. Clinical outcomes included a visual analog scale, Oswestry Disability Index, and EuroQol 5-dimension questionnaire (EQ-5D). Radiological parameters were measured using whole-spine standing lateral radiographs. Fusion, loosening, subsidence rates, and adverse events were also evaluated. Patients were divided into two groups according to their preoperative C7–S1 sagittal vertical axis (SVA): Group N: SVA≤5?cm vs Group I: SVA>5?cm; they were also divided according to postoperative changes in C7–S1 SVA. Clinical and radiological outcomes were compared between the groups.

Results

All clinical outcomes and radiological parameters improved postoperatively. C7–S1 SVA improved (?1.6?cm) after L3–L5 fusion, but it was compromised (+3.6?cm) after L4–S1 fusion (p=.001). Preoperative demographic and clinical data showed no difference except in the anxiety or depression domain of EQ-5D. No differences were found in postoperative clinical outcomes. Lumbar lordosis, pelvic tilt, and thoracic kyphosis slightly improved in Group N, whereas C7–S1 SVA decreased from 9.5?cm to 3.8?cm (p<.001) in Group I. Furthermore, all sagittal parameters improved in Group I. On comparing the postoperative changes in C7–S1 SVA, we found that the decreasing trend in the postoperative C7–S1 SVA was related to a larger preoperative C7–S1 SVA (p=.030) and a more proximal level fusion (L3–L5 vs L4–S1, p=.033).

Conclusions

Global sagittal balance improved after short-level lumbar fusion surgery in patients having spinal stenosis with spondylolisthesis who showed preoperative sagittal imbalance. Restoration of sagittal balance predominantly occurred after L3–L4, L4–L5, or L3–L5 PLIF. However, no such restoration was observed after L5–S1 or L4–S1 PLIF. Thus, we could anticipate sagittal balance restoration after performing PLIF at L3–L4 or L4–L5 level. However, caution is required when planning for L5–S1 fusion if preoperative sagittal imbalance is present.  相似文献   

11.

Background Context

There is a paucity of literature describing risk factors for adverse outcomes after geriatric lumbar spinal surgery. As the geriatric population increases, so does the number of lumbar spinal surgeries in this cohort.

Purpose

The purpose of the study was to determine how safe lumbar surgery is in elderly patients. Does patient selection, type of surgery, length of surgery, and other comorbidities in the elderly patient affect complication and readmission rates after surgery?

Study Design/Setting

This is a retrospective cohort study.

Patient Sample

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Database was used in the study.

Outcome Measures

The outcome data that were analyzed were minor and major complications, mortality, and readmissions in geriatric patients who underwent lumbar spinal surgery from 2005 to 2015.

Materials and Methods

A retrospective cohort study was performed using data from the ACS NSQIP database. Patients over the age of 80 years who underwent lumbar spinal surgery from 2005 to 2013 were identified using International Statistical Classification of Diseases and Related Health Problems diagnosis codes and Current Procedural Terminology codes. Outcome data were classified as either a major complication, minor complication, readmission, or mortality. Multivariate logistic regression models were used to determine risks for developing adverse outcomes in the initial 30 postoperative days.

Results

A total of 2,320 patients over the age of 80 years who underwent lumbar spine surgery were identified. Overall, 379 (16.34%) patients experienced at least one complication or death. Seventy-five patients (3.23%) experienced a major complication. Three hundred thirty-eight patients (14.57%) experienced a minor complication. Eighty-six patients (6.39%) were readmitted to the hospital within 30 days. Ten deaths (0.43%) were recorded in the initial 30 postoperative days. Increased operative times were strongly associated with perioperative complications (operative time >180 minutes, odds ratio [OR]: 3.07 [95% confidence interval {CI} 2.23–4.22]; operative time 120–180 minutes, OR: 1.77 [95% CI 1.27–2.47]). Instrumentation and fusion procedures were also associated with an increased risk of developing a complication (OR: 2.56 [95% CI 1.66–3.94]). Readmission was strongly associated with patients who were considered underweight (body mass index [BMI] <18.5) and who were functionally debilitated at the time of admission (OR: 4.10 [1.08–15.48] and OR: 2.79 [1.40–5.56], respectively).

Conclusions

Elderly patients undergoing lumbar spinal surgery have high complications and readmission rates. Risk factors for complications include longer operative time and more extensive procedures involving instrumentation and fusion. Higher readmission rates are associated with low baseline patient functional status and low patient BMI.  相似文献   

12.

Background Context

The patient experience of care as measured by the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey is currently used to determine hospital reimbursement. The current literature inconsistently demonstrates an association between patient satisfaction and surgical outcomes.

Purpose

To determine whether patient satisfaction with hospital experience is associated with better clinical outcomes in lumbar spine surgery.

Study Design

A retrospective cohort study conducted at a single institution.

Patient Sample

A total of 249 patients who underwent lumbar spine surgery between 2013 and 2015 and completed the HCAHPS survey.

Outcome Measures

Self-reported health status measures, including the EuroQol 5 Dimensions (EQ-5D), Pain Disability Questionnaire (PDQ), and visual analog score for back pain (VAS-BP).

Methods

All patients undergoing lumbar spine surgery between 2013 and 2015 who completed an HCAHPS survey were studied. Patients were excluded from the study if they had been diagnosed with spinal malignancy, scoliosis, or had less than 1 year of follow-up. Patients who selected a 9 or 10 overall hospital rating (OHR) on HCAHPS were placed in the satisfied group, and the remaining patients comprised the unsatisfied group. The primary outcomes of this study include patient-reported health status measures such as EQ-5D, PDQ, and VAS-BP. No funds were received in support of this study, and the authors report no conflict of interest-associated biases.

Results

Our study population consisted of 249 patients undergoing lumbar spine surgery. Of these, 197 (79%) patients selected an OHR of 9 or 10 on the HCAHPS survey and were included in the satisfied group. The only preoperative characteristics that differed significantly between the twogroups were gender, a diagnosis of degenerative disc disease (DDD), heavy preoperative narcotic use, and a diagnosis of chronic renal failure. At 1 year follow-up, no statistically significant differences in EQ-5D, PDQ, or VAS-BP were observed. After using multivariable linear regression models to assess the association between patient satisfaction and pre- to 1-year postoperative changes in health status measures, selecting a top-box OHR was not found to be significantly associated with change in either EQ-5D (beta=0.055 [95% confidence interval {CI}: ?0.035 to 0.145]), PDQ (beta=?9.013 [95% CI: ?23.782 to 5.755]), or VAS-BP (beta=?0.849 [95% CI: ?2.125 to 0.426]). These results suggest high satisfaction with the hospital experience may not necessarily correlate with favorable clinical outcomes.

Conclusions

Top-box OHR was not associated with pre- to 1-year postoperative improvement in EQ-5D, PDQ, and VAS-BP. Although the associations between high satisfaction and improvement in health status did not reach statistical significance, the best estimates from our multivariable models reflect greater clinical improvement with top-box satisfaction. Future studies should seek to investigate whether HCAHPS are a reliable indicator of quality care in lumbar spine surgery.  相似文献   

13.

Background Context

Elective spine surgery is a commonly performed operative procedure, that requires knowledge of risk-adjusted results to improve outcomes and reduce costs.

Purpose

To develop risk-adjusted models to predict the adverse outcomes (AOs) of care during the inpatient and 90-day post-discharge period for spine fusion surgery.

Study Design/Setting

To identify the significant risk factors associated with AOs and to develop risk models that measure performance.

Patient Sample

Hospitals that met minimum criteria of both 20 elective cervical and 20 elective non-cervical spine fusion operations in the 2012–2014 Medicare limited dataset.

Outcome Measures

The risk-adjusted AOs of inpatient deaths, prolonged length-of-stay for the index hospitalization, 90-day post-discharge deaths, and 90-day post-discharge readmissions were dependent variables in predictive risk models.

Methods

Over 500 candidate risk factors were used for logistic regression models to predict the AOs. Models were then used to predicted risk-adjusted AO rates by hospitals.

Results

There were 874 hospitals with a minimum of both 20 cervical and 20 non-cervical spine fusion patients. There were 167,395 total cases. A total of 7,981 (15.9%) of cervical fusion patients and 17,481 (14.9%) of non-cervical fusion patients had one or more AOs for an overall AO rate of 15.2%. A total of 54 hospitals (6.2%) had z-scores that were 2.0 better than predicted with a median risk adjusted AO rate of 9.2%, and 75 hospitals (8.6%) were 2.0 z-scores poorer than predicted with a median risk-adjusted AO rate of 23.2%.

Conclusions

Differences among hospitals defines opportunities for care improvement.  相似文献   

14.

Background Context

Medical interventional modalities such as lumbar epidural steroid injections (LESIs) are often used in the setting of lumbar spine disorders where other conservative measures have failed. Concomitant depression can lead to worse outcomes in lumbar spine pathology. A number of studies have demonstrated an association between preoperative depression and poor outcomes following surgery, but the effect of depression on outcomes following medical interventional modalities is poorly understood.

Purpose

To evaluate the differences in patient-reported outcomes (PROs) between depressed and non-depressed patients undergoing LESI.

Study Design/Setting

This study is an analysis of a prospective longitudinal registry database at a single academic institution.

Patient Sample

All patients undergoing LESI from 2012 to 2014 were eligible for enrollment into a prospective, web-based registry. Eligible patients had radicular pain, correlative imaging findings of degenerative pathology, and failed 6 weeks of conservative care.

Outcome Measures

The PROs measured included the (1) numeric rating scale for back pain (NRS-BP), (2) numeric rating scale for leg pain (NRS-LP), (3) disease-specific physical disability—Oswestry Disability Index (ODI), and (4) preference-based health status—EuroQol-5D (EQ-5D).

Materials and Methods

Patients who met the inclusion criteria underwent LESI. Patient-reported outcomes were collected at baseline and at 12 months following treatment. Based on previously validated values for the Zung Depression Scale (ZDS) as a screening tool for depression, patients were dichotomized into non-depressed (ZDS score ≤33) and depressed (ZDS score >33). The PRO change scores from baseline to 12 months were calculated. The mean absolute and change scores between the groups were compared using Student t test. Multivariable linear regression analysis for ODI, EQ-5D, NRS-LP, and NRS-BP was performed.

Results

A total of 161 patients with complete 12-month follow-up were included. Seventy-one patients (44%) were classified as depressed and 90 patients (56%) were classified as non-depressed. The mean baseline PRO scores were significantly worse in depressed patients compared with non-depressed patients: ODI (p<.001), NRS-BP (p=.013), NRS-LP (p<.001), and EQ-5D (p=.001). The mean absolute scores at 12 months were significantly lower in the depressed versus non-depressed patients: ODI (p<.001), NRS-BP (p=.001), NRS-LP (p=.05), and EQ-5D (p=.003). However, there was no difference in mean change scores observed at 12 months between the depressed and non-depressed cohorts: ODI (p=.42), NRS-BP (p=.31), NRS-LP (p=.25), EQ-5D (p=.14). Adjusting for pre-procedure variables, the higher ZDS score was associated with higher disability (ODI) at 12 months.

Conclusions

Depression led to worse absolute scores for PROs and is associated with higher disability following LESI. However, patients with depressive symptoms can expect similar improvement in PROs at 12 months.  相似文献   

15.

Background Context

General questionnaires are often used to assess quality of life in patients with spine metastases, although a disease-specific survey did not exist until recently. The Spine Oncology Study Group has developed an outcomes questionnaire (SOSG-OQ) to measure quality of life in these patients. However, a scoring system was not developed, and the questionnaire was not validated in a group of patients, nor was it compared with other general quality of life questionnaires such as the EuroQol 5 Dimensions (EQ-5D) questionnaire.

Purpose

Our primary null hypothesis is that there is no association between the SOSG-OQ and EQ-5D. Our secondary null hypothesis is that there is no difference in coverage and internal consistency between the SOSG-OQ and EQ-5D. We also assess coverage, consistency, and validity of the domains within the SOSG-OQ.

Study Design/Setting

A survey study from a tertiary care spine referral center was used for this study.

Patient Sample

The patient sample consisted of 82 patients with spine metastases, myeloma, or lymphoma.

Outcome Measures

The SOSG-OQ (27 questions, 6 domains) score ranges from 0 to 80, with a higher score indicating worse quality of life. The EQ-5D (5 questions, 5 domains) index score ranges from 0 to 1, with a higher score indicating better quality of life.

Methods

The association between the SOSG-OQ and EQ-5D index score was assessed using the Spearman rank correlation. Instrument coverage and precision were assessed by determining item completion rate, median score with range, and floor and ceiling effect. Internal consistency was assessed using Cronbach alpha. Multitrait analysis and exploratory factor analysis were used to analyze properties of the individual domains in the SOSG-OQ.

Results

The Spearman rank correlation between the SOSG-OQ and EQ-5D questionnaire was high (r=?0.83, p<.001). Internal consistency of the SOSG-OQ (0.92, 95% CI: 0.89–0.94) was higher as compared to the internal consistency of the EQ-5D (0.73, 95% CI: 0.63–0.84; p<.001). The SOSG-OQ score had no floor or ceiling effect indicating good coverage (median 30, range 3–64), whereas the EQ-5D had a ceiling effect of 10% (median 0.71, range 0.05–1).

Conclusions

In conclusion, our study proposes a scoring methodology—after reversing four inversely scored items—for the SOSG-OQ and shows that the questionnaire is a valid tool for the assessment of quality of life in patients with metastatic spine disease. The SOSG-OQ is superior to the EQ-5D in terms of coverage and internal consistency but consists of more questions.  相似文献   

16.

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   

17.

Background Context

Flexion radiographs have been used to identify cases of spinal instability. However, current methods are not standardized and are not sufficiently sensitive or specific to identify instability.

Purpose

This study aimed to introduce a new slump sitting method for performing lumbar spine flexion radiographs and comparison of the angular range of motions (ROMs) and displacements between the conventional method and this new method.

Study Design

This study used is a prospective study on radiological evaluation of the lumbar spine flexion ROMs and displacements using dynamic radiographs.

Patient Sample

Sixty patients were recruited from a single spine tertiary center.

Outcome Measure

Angular and displacement measurements of lumbar spine flexion were carried out.

Method

Participants were randomly allocated into two groups: those who did the new method first, followed by the conventional method versus those who did the conventional method first, followed by the new method. A comparison of the angular and displacement measurements of lumbar spine flexion between the conventional method and the new method was performed and tested for superiority and non-inferiority.

Results

The measurements of global lumbar angular ROM were, on average, 17.3° larger (p<.0001) using the new slump sitting method compared with the conventional method. They were most significant at the levels of L3–L4, L4–L5, and L5–S1 (p<.0001, p<.0001 and p=.001, respectively). There was no significant difference between both methods when measuring lumbar displacements (p=.814).

Conclusion

The new method of slump sitting dynamic radiograph was shown to be superior to the conventional method in measuring the angular ROM and non-inferior to the conventional method in the measurement of displacement.  相似文献   

18.

Background Context

Physical therapy is commonly sought by people with lumbar disc herniation and associated radiculopathy. It is unclear whether physical therapy is effective for this population.

Purpose

To determine the effectiveness of physical therapist-delivered individualized functional restoration as an adjunct to guideline-based advice in people with lumbar disc herniation and associated radiculopathy.

Study Design

This is a preplanned subgroup analysis of a multicenter parallel group randomized controlled trial.

Patient Sample

The study included 54 participants with clinical features of radiculopathy (6-week to 6-month duration) and imaging showing a lumbar disc herniation.

Outcome Measures

Primary outcomes were activity limitation (Oswestry Disability Index) and separate 0–10 numerical pain rating scales for leg pain and back pain. Measures were taken at baseline and at 5, 10, 26, and 52 weeks.

Methods

The participants were randomly allocated to receive either individualized functional restoration incorporating advice (10 sessions) or guideline-based advice alone (2 sessions) over a 10-week period. Treatment was administered by 11 physical therapists at private clinics in Melbourne, Australia.

Results

Between-group differences for activity limitation favored the addition of individualized functional restoration to advice alone at 10 weeks (7.7, 95% confidence interval [CI] 0.3–15.1) and 52 weeks (8.2, 95% CI 0.7–15.6), as well as back pain at 10 weeks (1.4, 95% CI 0.2–2.7). There were no significant differences between groups for leg pain at any follow-up. Several secondary outcomes also favored individualized functional restoration over advice.

Conclusions

In participants with lumbar disc herniation and associated radiculopathy, an individualized functional restoration program incorporating advice led to greater reduction in activity limitation at 10- and 52-week follow-ups compared with guideline-based advice alone. Although back pain was significantly reduced at 10 weeks with individualized functional restoration, this effect was not maintained at later timepoints, and there were no significant effects on leg pain, relative to guideline-based advice.  相似文献   

19.

Background Context

The oblique lateral interbody fusion (OLIF) procedure is aimed at mitigating some of the challenges seen with traditional anterior lumbar interbody fusion (ALIF) and transpsoas lateral lumbar interbody fusion (LLIF), and allows for interbody fusion at L1–S1.

Purpose

The study aimed to describe the OLIF technique and assess the complication and fusion rates.

Study Design

This is a retrospective cohort study.

Patient Sample

The sample is composed of 137 patients who underwent OLIF procedure.

Outcome Measures

The outcome measures were adverse events within 6 months of surgery: infection, symptomatic pseudarthrosis, hardware failure, vascular injury, perioperative blood transfusion, ureteral injury, bowel injury, renal injury, prolonged postoperative ileus (more than 3 days), incisional hernia, pseudohernia, reoperation, neurologic deficits (weakness, numbness, paresthesia), hip flexion pain, retrograde ejaculation, sympathectomy affecting lower extremities, deep vein thrombosis, pulmonary embolism, myocardial infarction, pneumonia, and cerebrovascular accident. The outcome measures also include fusion and subsidence rates based on computed tomography (CT) done at 6 months postoperatively.

Methods

Retrospective chart review of 150 consecutive patients was performed to examine the complications associated with OLIF at L1–L5 (OLIF25), OLIF at L5–S1 (OLIF51), and OLIF at L1–L5 combined with OLIF at L5–S1 (OLIF25+OLIF51). Only patients who had at least 6 months of postoperative follow-up, including CT scan at 6 months after surgery, were included. Independent radiology review of CT data was performed to assess fusion and subsidence rates at 6 months.

Results

A total of 137 patients underwent fusion at 340 levels. An overall complication rate of 11.7% was seen. The most common complications were subsidence (4.4%), postoperative ileus (2.9%), and vascular injury (2.9%). Ileus and vascular injuries were only seen in cases including OLIF51. No patient suffered neurologic injury. No cases of ureteral injury, sympathectomy affecting the lower extremities, or visceral injury were seen. Successful fusion was seen at 97.9% of surgical levels.

Conclusions

Oblique lateral interbody fusion is a safe procedure at L1–L5 as well as L5–S1. The complication profile appears acceptable when compared with LLIF and ALIF. The oblique trajectory mitigates psoas muscle and lumbosacral plexus-related complications seen with the lateral transpsoas approach. Furthermore, there is a high fusion rate based on CT data at 6 months.  相似文献   

20.

Background Context

The incidence of adverse care quality events among patients undergoing cervical fusion surgery is unknown using the definition of care quality employed by the Centers for Medicare and Medicaid Services (CMS). The effect of insurance status on the incidence of these adverse quality events is also unknown.

Purpose

This study determined the incidence of hospital-acquired conditions (HAC) and patient safety indicators (PSI) in patients with cervical spine fusion and analyzed the association between primary payer status and these adverse events.

Study Design

This is a retrospective cohort design.

Patient Sample

All patients in the Nationwide Inpatient Sample (NIS) aged 18 and older who underwent cervical spine fusion from 1998 to 2011 were included.

Outcome Measures

Incidence of HAC and PSI from 1998 to 2011 served as outcome variables.

Methods

We queried the NIS for all hospitalizations that included a cervical fusion during the inpatient episode from 1998 to 2011. All comparisons were made between privately insured patients and Medicaid or self-pay patients because Medicare enrollment is confounded with age. Incidence of nontraumatic HAC and PSI was determined using publicly available lists of International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes. We built logistic regression models to determine the effect of primary payer status on PSI and nontraumatic HAC.

Results

We identified 419,424 hospitalizations with cervical fusion performed during an inpatient episode. The estimated national incidences of nontraumatic HAC and PSI were 0.35% and 1.6%, respectively. After adjusting for patient demographics and hospital characteristics, Medicaid or self-pay patients had significantly greater odds of experiencing one or more HAC (odds ratio [OR] 1.51 95% conflict of interest [CI] 1.23–1.84) or PSI (OR 1.52 95% CI 1.37–1.70) than the privately insured cohort.

Conclusions

Among patients undergoing inpatient cervical fusion, primary payer status predicts PSI and HAC (both indicators of adverse health-care quality used to determine hospital reimbursement by CMS). As the US health-care system transitions to a value-based payment model, the cause of these disparities must be studied to improve the quality of care delivered to vulnerable patient populations.  相似文献   

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