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1.

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   

2.
Background contextPatient satisfaction ratings are increasingly being used in health care as a proxy for quality and are becoming the focal point for several quality improvement initiatives. Affective disorders, such as depression, have been shown to influence patient-reported outcomes and self-interpretation of health status. We hypothesize that patient psychiatric profiles influence reported satisfaction with care, independent of surgical effectiveness.PurposeTo assess the predictive value of preoperative depression on patient satisfaction after revision surgery for same-level recurrent stenosis.Study designRetrospective cohort study.Patient sampleFifty-three patients undergoing a revision surgery for symptomatic same-level recurrent stenosis.Outcome measuresPatient-reported outcome measures were assessed using an outcomes questionnaire that included questions on health state values (EuroQol-5D [EQ-5D]), disability (Oswestry Disability Index [ODI]), pain (visual analog scale [VAS]), depression (Zung self-rating depression scale), and Short Form 12 (SF-12) physical and mental component scores (PCS and MCS). Patient satisfaction was dichotomized as either “YES” or “NO” on whether they were satisfied with their surgical outcome 2 years after the surgery.MethodsA total of fifty-three patients undergoing revision neural decompression and instrumented fusion for same-level recurrent stenosis-associated back and leg pain were included in this study. Preoperative Zung self-rating depression score (ZDS), education status, comorbidities, and postoperative satisfaction with surgical care and outcome was assessed for all patients. Baseline and 2-year VAS for leg pain (VAS-LP), VAS for low back pain (VAS-BP), ODI, SF-12 PCS and MCS, and health-state utility (EQ-5D) were assessed. Factors associated with patient satisfaction after surgery were assessed via multivariate logistic regression analysis.ResultsTwo years after surgery, a significant improvement was reported in all outcome measures: VAS-BP (5±2.94 vs. 9.28±1, p<.001), VAS-LP (3.43±2.95 vs. 9.5±0.93, p<.001), ODI (21.75±12.07 vs. 36.01±6, p<.001), SF-12 PCS (32.30±11.01 vs. 25.13±5.84, p<.001), SF-12 MCS (47.48±10.96 vs. 34.91±12.77, p<.001), EQ-5D (0.60±0.31 vs. 0.18±0.22, p<.001), and ZDS (37.52±11.98 vs. 49.90±10.88, p<.001). Independent of postoperative improvement in pain and disability (surgical effectiveness), increasing preoperative Zung depression score was significantly associated with patient dissatisfaction 2 years after revision lumbar surgery (Odds ratio=0.67 [confidence interval: 0.38, 0.87], p<.001).ConclusionsOur study suggests that independent of the surgical effectiveness, the extent of preoperative depression influences the reported patient satisfaction after revision lumbar surgery. Quality improvement initiatives using patient satisfaction as a proxy for quality should account for the patients' baseline depression as potential confounders.  相似文献   

3.
《The spine journal》2021,21(9):1489-1496
Background contextCriteria for success after surgical treatment of lumbar spinal stenosis (LSS) have been defined previously; however, there are no clear criteria for failure and worsening after surgery as assessed by patient-reported outcome measures (PROMs).PurposeWe aimed to quantify changes in standard PROMs that most accurately identified failure and worsening after surgery for LSS.Study design /settingRetrospective analysis of prospective national spine registry data with 12-months follow-up.Patient sampleWe analyzed 10,822 patients aged 50 years and older operated in Norway during a decade, and 8,258 (76%) responded 12 months after surgery.Outcome measures (PROMs)We calculated final scores, absolute changes, and percentage changes for Oswestry Disability Index (ODI), Numeric Rating Scale (NRS) for back and leg pain (0-10), and EuroQol-5D (EQ-5D). These 12 PROM derivates were compared to the Global Perceived Effect (GPE), a 7-point Likert scale.MethodsWe used ODI, NRS back and leg pain, and EQ-5D 12 months after surgery to identify patients with failure (no effect) and worsening (clinical deterioration). The corresponding GPE at 12-months was graded as failure (GPE=4-7) and worsening (GPE=6-7) and used as an external criterion. To quantify the most accurate cut-off values corresponding to failure and worsening, we calculated areas under the curves (AUCs) of receiver operating characteristics (ROC) curves for the respective PROM derivates.ResultsMean (95% CI) age was 68.3 (68.1 – 68.5) years, and 52% were females. There were 1,683 (20%) failures, and 476 (6%) patients were worse after surgery. The mean (95% CI) pre- and postoperative ODIs were 39.8 (39.5 – 40.2) and 23.7 (23.3 – 24.1), respectively. At 12 months, the mean difference (95% CI) in ODI was 16.1 (15.7 – 16.4), and the mean (95% CI) percentage improvement 38.8% (37.8 – 38.8).The PROM derivates identified failure and worsening accurately (AUC>0.80), except for the absolute change in EQ-5D. The ODI derivates were most accurate to identify both failure and worsening. We found that less than 20% improvement in ODI most accurately identified failure (AUC=0.89 [95% CI: 0.88 to 0.90]), and an ODI final score of 39 points or more most accurately identified worsening (AUC =0.91 [95% CI: 0.90 – 0.92]).ConclusionsIn this national register study, ODI derivates were most accurate to identify both failure and worsening after surgery for degenerative lumbar spinal stenosis. We recommend use of ODI percentage change and ODI final score for further studies of failure and worsening in elective spine surgery.  相似文献   

4.
BackgroundValidity and responsiveness of Oswestry disability index (ODI), Roland Morris disability questionnaires (RMDQ), Short Form-12 Physical Component Score (SF-12 PCS) and Short Form-12 Mental Component Score (SF-12 MCS) in patients undergoing open decompression for lumbar canal stenosis has not been previously reported.MethodsOutcome assessment was prospectively evaluated using the ODI, RMDQ, SF-12 PCS and SF-12 MCS pre-intervention and at average follow-up of three months post-intervention. Pearson correlation coefficient was used to evaluate the association between change in values of ODI, RMDQ, SF-12 PCS and SF-12 MCS. Distribution based methods (Effect size [ES], standardised response mean [SRM]) and anchor based method (Area under the curve [AUC] of receiver operating curve [ROC]) were used to determine responsiveness. AUC value ≥ 0.70 is considered as adequate level of responsiveness and the outcome instrument with the largest AUC is considered to be the most responsive outcome instrument.ResultsThis study included 77 participants. Responsiveness was assessed at a mean follow-up of 12 weeks postoperatively. There was significant strong correlation between ODI and RMDQ (r = 0.65, p < 0.0001). The ES of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 1.54, 1.48, 1.85 and 0.51 respectively. The SRM of RMDQ, ODI, SF-12 PCS and SF-12 MCS were 1.22, 1.17, 1.0 and 0.47 respectively. AUC of ODI, RMDQ, SF-12 PCS and SF-12 MCS were 0.83–0.88, 0.82 to 0.86, 0.78 to 0.81 and 0.69 to 0.70 respectively.ConclusionIt is recommended to use either ODI or RMDQ as region specific patient reported outcome instrument and SF-12 PCS as a health related quality of life outcome instrument to evaluate outcome after decompressive laminectomy for lumbar canal stenosis.  相似文献   

5.
Background contextGiven the unsustainable costs of the US health-care system, health-care purchasers, payers, and hospital systems are adopting the concept of value-based purchasing by shifting care away from low-quality providers or hospitals. Legislation now allows public reporting of these quality rankings. True measures of quality, such as surgical morbidity and validated questionnaires of effectiveness, are burdensome and costly to collect. Hence, patients' satisfaction with care has emerged as a commonly used metric as a proxy for quality because of its feasibility of collection. However, patient satisfaction metrics have yet to be validated as a measure of overall quality of surgical spine care.PurposeWe set out to determine whether patient satisfaction is a valid measure of safety and effectiveness of care in a prospective longitudinal spine registry.Study designProspective longitudinal cohort study.Patient populationAll patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center.Outcome measuresPatient-reported outcome instruments (numeric rating scale [NRS], Oswestry disability index [ODI], neck disability index [NDI], short-form 12-item survey [SF-12], Euro-Qol-5D [EQ-5D], Zung depression scale, and Modified Somatic Perception Questionnaire [MSPQ] anxiety scale), return to work, patient satisfaction with outcome, and patient satisfaction with provider care.MethodsAll patients undergoing elective spine surgery for degenerative conditions over a 6-month period at a single medical center were enrolled into a prospective longitudinal registry. Data collected on all patients included demographics, disease characteristics, treatment variables, readmissions/reoperations, and all 90-day surgical morbidity. Patient-reported outcome instruments (NRS, ODI, NDI, SF-12, EQ-5D, Zung depression scale, and MSPQ anxiety scale), return to work, patient satisfaction with outcome, and patient satisfaction with provider care were recorded at baseline and 3 months after treatment. Receiver-operating characteristic (ROC) curve analysis was performed to determine whether extent of improvement in quality of life (SF-12 physical component summary [PCS]) and disability (ODI/NDI) accurately predicted patient satisfaction versus dissatisfaction. Standard interpretation of area under the curve (AUC) was used: less than 0.7, poor; 0.7 to 0.8, fair; and greater than 0.8, good accuracy. Multivariate logistic regression analysis was performed to determine if surgical morbidity (quality) or improvement in disability and quality of life (effectiveness of care) were independently associated with patient satisfaction.ResultsFour hundred twenty-two (84%) patients completed all questionnaires 3 months after surgery during the reviewed time period (mean age 55±14 years). Lumbar surgery was performed in 287 (68%) and cervical surgery in 135 (32%) patients. There were 51 (12.1%) 90-day complications, including 21 (5.0%) readmissions and 12 (2.8%) return to operating room. Three hundred fifty-eight (84.8%) patients were satisfied with provider care and 288 (68.2%) with their outcome. Satisfaction with provider care: In ROC analyses, extent of improvement in quality of life (SF-12) and disability (ODI/NDI) differentiated satisfaction versus dissatisfaction with care with very poor accuracy (AUC 0.49–0.69). In regression analysis, 3-month morbidity (odds ratio [95% confidence interval]: 1.45 [0.79–2.66]), readmission (0.66 [0.24–1.80]), improvement in quality of life (SF-12 PCS), or improvement in general health (health transition index) were not associated with satisfaction with care. Satisfaction with outcome: In ROC analyses, improvement in quality of life (SF-12) and disability (ODI/NDI) failed to differentiate satisfaction with good accuracy (AUC 0.76). Neither 90-day morbidity (1.05 [0.46–2.34]) nor 90-day readmission (0.27 [0.04–2.04]) was associated with satisfaction with outcome in regression analysis.ConclusionsPatient satisfaction is not a valid measure of overall quality or effectiveness of surgical spine care. Patient satisfaction metrics likely represent the patient's subjective contentment with health-care service, a distinct aspect of care. Satisfaction metrics are important patient-centered measures of health-care service but should not be used as a proxy for overall quality, safety, or effectiveness of surgical spine care.  相似文献   

6.

BACKGROUND

In modern clinical research, the accepted minimum follow-up for patient-reported outcome measures (PROMs) after lumbar spine surgery is 24 months, particularly after fusion. Recently, this minimum requirement has been called into question.

PURPOSE

We aim to quantify the concordance of 1- and 2-year PROMs to evaluate the importance of long-term follow-up after elective lumbar spine surgery.

STUDY DESIGN

Retrospective analysis of data from a prospective registry.

PATIENT SAMPLE

We identified all patients in our prospective institutional registry who underwent degenerative lumbar spine surgery with complete baseline, 12-month, and 24-month follow-up for ODI and numeric rating scales for back and leg pain (NRS-BP and NRS-LP).

OUTCOME MEASURES

Oswestry Disability Index (ODI) and NRS-BP and NRS-LP at 1 year and at 2 years.

METHODS

We evaluated concordance of 1- and 2-year change scores by means of Pearson's product-moment correlation and performed logistic regression to assess if achieving the minimum clinically important difference (MCID) at 12 months predicted 24-month MCID. Odds ratios (OR) and their 95% confidence intervals (CI), as well as model areas-under-the-curve were obtained.

RESULTS

A total of 210 patients were included. We observed excellent correlation among 12- and 24-month ODI (r?=?0.88), NRS-LP (r?=?0.76) and NRS-BP (r?=?0.72, all p <.001). Equal results were obtained when stratifying for discectomy, decompression, or fusion. Patients achieving 12-month MCID were likely to achieve 24-month MCID for ODI (OR: 3.3, 95% CI: 2.4–4.1), NRS-LP (OR: 2.99, 95% CI: 2.2–4.2) and NRS-BP (OR: 3.4, 95% CI: 2.7–4.2, all p <.001) with excellent areas-under-the-curve values of 0.81, 0.77, and 0.84, respectively. Concordance rates between MCID at both follow-ups were 87.2%, 83.8%, and 84.2%. A post-hoc power analysis demonstrated sufficient statistical power.

CONCLUSIONS

Irrespective of the surgical procedure, 12-month PROMs for functional disability and pain severity accurately reflect those at 24 months. In support of previous literature, our results suggest that 12 months of follow-up may be sufficient for evaluating spinal patient care in clinical practice as well as in research.  相似文献   

7.
Background contextEffective alternatives to lumbar fusion for degenerative conditions have remained elusive. Anterior total disc replacement does not address facet pathology or central/recess stenosis, resulting in limited indications. A posterior-based motion-preserving option that allows for neural decompression, facetectomy, and reconstruction of the disc and facets may have a role.PurposeThe purpose was to compare one-year patient-reported outcomes for a novel, all-posterior, lumbar total joint replacement (LTJR – replacing both the disc and facet joints) against transforaminal lumbar interbody fusion (TLIF) for degenerative lumbar conditions warranting fusion (degenerative spondylolisthesis, recurrent disc herniation, severe foraminal stenosis requiring facet removal, and adjacent segment degeneration).Study design/settingA retrospective analysis of prospectively collected data comparing outcomes for LTJR patients to TLIF patients at an academic teaching hospital.Patient sampleAnalysis was conducted on 156 adult TLIF patients who were propensity matched to the 52 LTJR patients for a total sample of 208.Outcome measuresSelf-reported Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) for back and leg pain were compared preoperatively, 3 months and 1 year after surgery.MethodsThe implant is a motion-preserving lumbar reconstruction that replaces the function of both the disc and facets and is implanted using a bilateral transforaminal approach with complete facetectomies. Adult patients with degenerative lumbar pathology undergoing either LTJR or open TLIF were analyzed. These degenerative conditions included: grade 1 degenerative spondylolisthesis, recurrent disc herniation, adjacent segment disease, disc degeneration with severe foraminal stenosis). Trauma, tumor, grade 2 or higher spondylolisthesis, spinal deformity, and infection cases were excluded. Propensity score matching was performed to ensure parity between the cohorts. Multivariable regression analyses were done to compare the 1-year results as measured by 3 different standards to assess procedure success.ResultsAt 3 months, both the LTJR and TLIF cohorts showed significant and similar improvements in ODI and NRS back and leg pain. At 1 year, the LTJR cohort showed continued improvement in ODI and NRS back pain, while the TLIF group showed a plateau for ODI, back and leg pain. In a series of three multivariable logistic regressions, LTJR was shown to provide 3.3 times greater odds of achieving the minimal clinical symptom state in disability and pain (ODI <20%, NRS back and leg pain <2) and 2.4 and 4.1 times greater odds of achieving substantial clinical benefit (18% reduction in ODI) and minimal clinically important difference (30% reduction in ODI) as compared to TLIF.ConclusionsHere we present a comparative analysis for the first 52 patients undergoing a novel, posterior-based LTJR for the lumbar spine versus TLIF for degenerative pathology. The approach for the LTJR allows for wide neural decompression, facetectomy, and complete discectomy, with the implant working to replace the function of the disc and facets to preserve motion. At 1 year, the LTJR cohort showed significant improvement in ODI and NRS back and leg pain as compared to TLIF. These results suggest that wide neural decompression combined with motion preservation using this novel LTJR may represent a viable alternative to TLIF for treating certain degenerative conditions. A prospective controlled trial is under development to further evaluate the efficacy, safety, and durability of this procedure.  相似文献   

8.
《Acta orthopaedica》2013,84(6):732-736
Background and purpose Several studies have investigated outcomes after disc surgery. However, the occurrence of kinesiophobia has not been investigated previously in patients after disc herniation surgery. In this cross-sectional study, we investigated kinesiophobia in patients who had been treated surgically for lumbar disc herniation, and we related the results to established outcome measures.

Patients and methods 10–34 months after surgery, questionnaires were sent to 97 patients who had undergone standardized open discectomy. Outcome measures included Tampa scale for kinesiophobia (TSK); Oswestry disability index (ODI); European quality of life in 5 dimensions (EQ-5D); visual analog scale (VAS) for leg and back pain, work disability, and patient satisfaction; Zung self-rating depression scale (ZDS); pain catastrophizing scale (PCS); and a self-efficacy scale (SES).

Results 36 of 80 patients reported having kinesiophobia. There were statistically significant differences in ODI, EQ-5D, VAS leg and back pain, ZDS, PCS, and SES between patients with and without kinesiophobia.

Interpretation Half of the patients suffered from kinesiophobia 10–34 months after surgery for disc herniation. These patients were more disabled, had more pain, more catastrophizing thoughts, more symptoms of depression, lower self-efficacy, and poorer health-related quality of life than patients without kinesiophobia.  相似文献   

9.

Background Context

Introduced in 2007, the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) has been widely used, but its psychometric properties have not been well studied.

Purpose

The objective of this study was to assess the responsiveness of the JOABPEQ in lumbar surgery and its threshold for indicating clinically important differences.

Study Design

This is a prospective study.

Patient Sample

Two hundred three consecutive patients underwent lumbar surgeries between July 2013 and November 2015 in a single hospital. Of the 203 patients, 181 patients who completed 1 year of follow-up were included.

Outcome Measures

Before and after surgery, the patients were asked to complete the questionnaire, including JOABPEQ, the 8-Item Short Form Health Survey (SF-8), and EuroQol-5D (EQ-5D). The participants were divided into five anchoring groups, ranging from “much better” to “much worse,” according to reports from both physicians and patients.

Materials and Methods

The responsiveness of measures was compared among five domains of the JOABPEQ (“low back pain,” “walking ability,” “lumbar function,” “social function,” and “mental health”), two domains of the SF-8 (the physical component summary [PCS] and the mental component summary [MCS]), and the EQ-5D. The responsiveness was assessed by the paired t test, the effect size, and the standardized response mean. The Spearman rank correlation coefficient and the receiver operating characteristic (ROC) curve were assessed using the five anchoring groups as external criteria. The clinically important differences, based on the ROC curve, were assessed.

Results

Walking ability was most responsive, followed by low back pain and the PCS. The MCS was least responsive, followed by mental health and lumbar function. Social function and the EQ-5D had intermediate-level responsiveness. The substantial clinically important differences occurred at 20 points for low back pain and lumbar function, 23 points for walking ability, 14 points for social function, and 8 points for mental health.

Conclusions

The JOABPEQ domains are responsive measures in patients who undergo lumbar surgery. For physical function, the threshold for substantial clinically important differences was approximately 20 points for the JOABPEQ.  相似文献   

10.
Background contextSpinal surgical outcome studies rely on patient reported outcome (PRO) measurements to assess the effect of treatment. A shortcoming of these questionnaires is that the extent of improvement in their numerical scores lacks a direct clinical meaning. As a result, the concept of minimum clinically important difference (MCID) has been used to measure the critical threshold needed to achieve clinically relevant treatment effectiveness. Post hoc anchor-based MCID methods have not been applied to the surgical treatment for pseudoarthrosis.PurposeTo determine the most appropriate MCID values for visual analog scale (VAS), Oswestry Disability Index (ODI), Short Form (SF)-12 physical component score (PCS), and European Quality of Life 5-Dimensions (EQ-5D) in patients undergoing revision lumbar arthrodesis for symptomatic pseudoarthrosis.Study design/ settingRetrospective cohort study.MethodsIn 47 patients undergoing revision fusion for pseudoarthrosis-associated back pain, PRO measures of back pain (BP-VAS), ODI, physical quality of life (SF-12 PCS), and general health utility (EQ-5D) were assessed preoperatively and 2 years postoperatively. Four subjective post hoc anchor-based MCID calculation methods were used to calculate MCID (average change; minimum detectable change; change difference; and receiver operating characteristic curve analysis) for two separate anchors (health transition index (HTI) of SF-36 and satisfaction index).ResultsAll patients were available for a 2-year PRO assessment. Two years after surgery, a significant improvement was observed for all PROs; Mean change score: BP-VAS (2.3±2.6; p<.001), ODI (8.6%±13.2%; p<.001), SF-12 PCS (4.0±6.1; p=.01), and EQ-5D (0.18±0.19; p<.001). The four MCID calculation methods generated a wide range of MCID values for each of the PROs (BP-VAS: 2.0–3.2; ODI: 4.0%–16.6%; SF-12 PCS: 3.2–6.1; and EQ-5D: 0.14–0.24). There was no difference in response between anchors for any patient, suggesting that HTI and satisfaction anchors are equivalent in this patient population. The wide variations in calculated MCID values between methods precluded any ability to reliably determine what the true value is for meaningful change in this disease state.ConclusionsUsing subjective post hoc anchor-based methods of MCID calculation, MCID after revision fusion for pseudoarthrosis varies by as much as 400% per PRO based on the calculation technique. MCID was suggested to be as low as 2 points for ODI and 3 points for SF-12. These wide variations and low values of MCID question the face validity of such calculation techniques, especially when applied to heterogeneous disease and patient groups with a multitude of psychosocial confounders such as failed back syndromes. The variability of MCID thresholds observed in our study of patients undergoing revision lumbar fusion for pseudoarthrosis raises further questions to whether ante hoc or Delphi methods may be a more valid and consistent technique to define clinically meaningful, patient-centered changes in PRO measurements.  相似文献   

11.
There is limited data on the cost-utility of low-back surgical procedures. The EuroQol-5D (EQ-5D) is a generic health-related quality of life (HRQL) instrument, which was designed for cost-utility analyses and for comparisons of therapeutic effects across different diseases. Disease-specific (HRQL) instruments cannot be used for such purposes. However, there is little evidence of the usefulness of the EQ-5D in the field of low-back surgery, and it might be too general to assess specific conditions. We therefore tested its validity and responsiveness against a widely used disease-specific HRQL instrument [the Oswestry disability index (ODI)], in a prospective study on 326 patients operated for degenerative disorders in the lumbar spine. The reliability of the EQ-5D was also evaluated. Follow-up time was 12 months. Cross-sectional construct validity of the EQ-5D and ODI in the assessments of pain, functional status, health state and employment status were equal. The ODI performed better only in the assessment of walking capability. Only small differences in responsiveness were found. The reliability of the EQ-5D was solid. Our results indicate that the EQ-5D is useful for estimating health state values and for monitoring outcome of patients undergoing low-back surgery. Hence, this instrument would provide valid data for cost–utility analyses.  相似文献   

12.
This study compared the outcomes of microendoscopy-assisted lumbar interbody fusion (ME-LIF) and uniportal full-endoscopic laminectomy (FEL) for L5 radiculopathy caused by lumbar foraminal stenosis (LFS). ME-LIF was performed using an 18- to 20-mm tubular retractor and endoscope, and FEL via the translaminar approach (TLA) was performed at the dorsal part of the foramen using a 4.1-mm working channel endoscope. Patients with LFS treated using ME-LIF (n = 39) or FEL-TLA (n = 30) were retrospectively evaluated. Patients'' background and operative data were collected. The 36-item Short Form Survey (SF-36), Oswestry Disability Index (ODI), and European Quality of Life-5 Dimension (EQ-5D) scores were recorded preoperatively and 2 years postoperatively. The background data of the two groups (ME-LIF and FEL-TLA) were similar. The mean operation times for ME-LIF and FEL-TLA were 110.7 and 65.2 min, respectively, and the mean length of hospital stay were 10.3 and 1.5 days, respectively. Reoperation was required for surgical site infection, and percutaneous pedicle screw malposition in three patients was treated using ME-LIF. During follow-up, second FEL-TLA and LIF were performed for recurrent L5 radiculopathy in one and three patients in the FEL-TLA group, respectively. Although the SF-36, ODI, and EQ-5D scores 2 years postoperatively improved in both groups, improvement in ODI scores was lower following FEL-TLA than following ME-LIF. FEL-TLA can be performed to treat patients with L5 radiculopathy caused by LFS. Although the ODI score improvement following FEL-TLA was unremarkable, FEL-TLA might be considered because of its better safety profile and minimal invasiveness than ME-LIF.  相似文献   

13.
《The spine journal》2023,23(1):54-63
BACKGROUND CONTEXTSurgical counseling enables shared decision-making (SDM) by improving patients’ understanding.PURPOSETo provide answers to frequently asked questions (FAQs) in minimally invasive lumbar spine surgery.STUDY DESIGNRetrospective review of prospectively collected data.PATIENT SAMPLEPatients who underwent primary tubular minimally invasive lumbar spine surgery in form of transforaminal lumbar interbody fusion (MI-TLIF), decompression alone, or microdiscectomy and had a minimum of 1-year follow-up.OUTCOME MEASURES(1) Surgical (radiation exposure and intraoperative complications) (2)Immediate postoperative (length of stay [LOS] and complications) (3) Clinical outcomes (Visual Analog Scale- back and leg, VAS; Oswestry Disability Index, ODI; 12-Item Short Form Survey Physical Component Score, SF-12 PCS; Patient-Reported Outcomes Measurement Information System Physical Function, PROMIS PF; Global Rating Change, GRC; return to activities; complications/reoperations)METHODSThe outcome measures were analyzed to provide answers to ten FAQs that were compiled based on the authors’ experience and a review of literature. Changes in VAS back, VAS leg, ODI, and SF-12 PCS from preoperative values to the early (<6 months) and late (>6 months) postoperative time points were analyzed with Wilcoxon Signed Rank Tests. % of patients achieving minimal clinically important difference (MCID) for these patient-reported outcome measures (PROMs) at the two time points was evaluated. Changes in PROs from preoperative values too early (<6 months) and late (≥6 months) postoperative time points were analyzed within each of the three groups. Percentage of patients achieving MCID was also evaluated.RESULTSThree hundred sixty-six patients (104 TLIF, 147 decompression, 115 microdiscectomy) were included. The following FAQs were answered: (1) Will my back pain improve? Most patients report improvement by >50%. About 60% of TLIF, decompression, and microdiscectomy patients achieved MCID at ≥6 months. (2) Will my leg pain improve? Most patients report improvement by >50%. 56% of TLIF, 67% of decompression, and 70% of microdiscectomy patients achieved MCID at ≥6 months. (3) Will my activity level improve? Most patients report significant improvement. Sixty-six percent of TLIF, 55% of decompression, and 75% of microdiscectomy patients achieved MCID for SF-12 PCS. (4) Is there a chance I will get worse? Six percent after TLIF, 14% after decompression, and 5% after microdiscectomy. (5) Will I receive a significant amount of radiation? The radiation exposure is likely to be acceptable and nearly insignificant in terms of radiation-related risks. (6) What is the likelihood that I will have a complication? 17.3% (15.4% minor, 1.9% major) for TLIF, 10% (9.3% minor and 0.7% major) for decompression, and 1.7% (all minor) for microdiscectomy (7) Will I need another surgery? Six percent after TLIF, 16.3% after decompression, 13% after microdiscectomy. (8) How long will I stay in the hospital? Most patients get discharged on postoperative day one after TLIF and on the same day after decompression and microdiscectomy. (9) When will I be able to return to work? >80% of patients return to work (average: 25 days after TLIF, 14 days after decompression, 11 days after microdiscectomy). (10) Will I be able to drive again? >90% of patients return to driving (average: 22 days after TLIF, 11 days after decompression, 14 days after microdiscectomy).CONCLUSIONSThese concise answers to the FAQs in minimally invasive lumbar spine surgery can be used by physicians as a reference to enable patient education.  相似文献   

14.
《The spine journal》2021,21(8):1332-1339
BACKGROUND CONTEXTSpine patients have a higher rate of depression then the general population which may be caused in part by levels of pain and disability from their spinal disease.PURPOSEDetermination whether improvements in health-related quality of life (HRQOL) resulting from successful spine surgery leads to improvements in mental health.STUDY DESIGN/SETTINGThe Canadian Spine Outcome Research Network prospective surgical outcome registry.OUTCOME MEASURESChange between preoperative and postoperative SF12 Mental Component Score (MCS). Secondary outcomes include European Quality of Life (EuroQoL) Healthstate, SF-12 Physical Component Score (PCS), Oswestry Disability Index (ODI), Patient Health Questionaire-9 (PHQ9), and pain scales.METHODSThe Canadian Spine Outcome Research Network registry was queried for all patients receiving surgery for degenerative thoracolumbar spine disease. Exclusion criteria were trauma, tumor, infection, and previous spine surgery. SF12 Mental Component Scores (MCS) were compared between those with and without significant improvement in postoperative disability (ODI) and secondary measures. Multivariate analysis examined factors predictive of MCS improvement.RESULTSEighteen hospitals contributed 3222 eligible patients. Worse ODI, EuroQoL, PCS, back pain and leg pain correlated with worse MCS at all time points. Overall, patients had an improvement in MCS that occurred within 3 months of surgery and was still present 24 months after surgery. Patients exceeding Minimally Clinically Important Differences in ODI had the greatest improvements in MCS. Major depression prevalence decreased up to 48% following surgery, depending on spine diagnosis.CONCLUSIONSLarge scale, real world, registry data suggests that successful surgery for degenerative lumbar disease is associated with reduction in the prevalence of major depression regardless of the specific underlaying diagnosis. Worse baseline MCS was associated with worse baseline HRQOL and improved postoperatively with coincident improvement in disability, emphasizing that mental wellness is not a static state but may improve with well-planned spine surgery.  相似文献   

15.
《The spine journal》2020,20(6):847-856
BACKGROUND CONTEXTMinimum clinically important difference (MCID) for patient-reported outcome measures is commonly used to assess clinical improvement. However, recent literature suggests that an absolute point-change may not be an effective or reliable marker of response to treatment for patients with low or high baseline patient-reported outcome scores. The multitude of established MCIDs also makes it difficult to compare outcomes across studies and different spine surgery procedures.PURPOSETo determine whether a 30% reduction from baseline in disability and pain is a valid method for determining clinical improvement after lumbar spine surgery.STUDY DESIGNRetrospective analysis of prospective data from a national spine registry, the Quality Outcomes Database.PATIENT SAMPLEThere were 23,280 participants undergoing elective lumbar spine surgery for degenerative disease who completed a baseline and follow-up assessment at 12 months.OUTCOME MEASURESPatient-reported disability (Oswestry Disability Index [ODI]), back and leg pain (11-point Numeric Rating Scale [NRS]), and satisfaction (NASS scale).METHODSPatients completed baseline and a 12-month postoperative assessment to evaluate the outcomes of disability, pain, and satisfaction. The change in ODI and NRS pain scores was categorized as met (≥30%) or not met (<30%) percent reduction MCID. The 30% reduction from baseline was compared with a wide range of well-established absolute point-change MCID values. The relationship between 30% reduction and absolute change values and satisfaction were primarily compared using receiver operating characteristic (ROC) curves, area under the curve (AUROC), and logistic regression analyses. Analyses were conducted for overall scores and for disability and pain severity categories and by surgical procedure.RESULTSThirty percent reduction in ODI and back and leg pain predicted satisfaction with more accuracy than absolute point-change values for the total population and across all procedure categories (p<.001), except for when compared with the highest absolute point-change threshold for leg pain (3.5-point reduction). The largest AUROC differences, in favor of 30% reduction, were found for the lowest disability (ODI 0–20%: 21.8%) and bed-bound disability (ODI 81%–100%: 13.9%) categories. For pain, there was a 3.4%–12.4% and 1.3%–9.8% AUROC difference for no/mild back and leg pain (NRS 0–4), respectively, in favor of a 30% reduction threshold.CONCLUSIONSA 30% reduction MCID either outperformed or was similar to absolute point-change MCID values. Results indicate that a 30% reduction (baseline to 12 months after surgery) in disability and pain is a valid method for determining clinically relevant improvement in a broad spine surgery population. Furthermore, a 30% reduction was most accurate for patients in the lowest and highest disability and lowest pain severity categories. A 30% reduction MCID allows for a standard cut-off for disability and pain that can be used to compare outcomes across various spine surgery procedures.  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.

Purpose

The purpose of this study was to compare patient-reported outcomes (PROs), morbidity, and costs of TLIF vs PLF to determine whether one treatment was superior in the setting of single-level degenerative spondylolisthesis.

Methods

Patients undergoing TLIF or PLF for single-level spondylolisthesis were included for retrospective analysis. EQ-5D, ODI, SF-12 MCS/PCS, NRS-BP/LP scores were collected at baseline and 24 months after surgery. 90-day post-operative complications, revision surgery rates, and satisfaction scores were also collected. Two-year resource use was multiplied by unit costs based on Medicare payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Total cost was used to assess mean total 2-year cost per QALYs gained after surgery.

Results

62 and 37 patients underwent TLIF and PLF, respectively. Patients in the PLF group were older (p < 0.01). No significant differences were seen in baseline or 24-month PROs between the two groups. There was a significant improvement in all PROs from baseline to 24 months after surgery (p < 0.001). Both groups had similar rates of 90-day complications, revision surgery, satisfaction, and similar gain in QALYs and cost per QALYs gained. There was no significant difference in 24-month direct, indirect, and total cost.

Conclusions

Overall costs and health care utilization were similar in both the groups. Both TLIF and PLF for single-level degenerative spondylolisthesis provide improvement in disability, pain, quality of life, and general health.
  相似文献   

18.
《The spine journal》2022,22(10):1687-1693
BACKGROUND CONTEXTTransforaminal lumbar interbody fusion (TLIF) with bilateral pedicle screw fixation (BPSF) is an effective treatment for lumbar foraminal stenosis (LFS). However, the effects of TLIF with unilateral pedicle screw fixation (UPSF) on LFS treatment have not been clearly elucidated.PURPOSEWe conducted this study to compare clinical outcomes and radiographic results of TLIF with UPSF and BPSF 2 years after the surgical treatment.DESIGNProspective randomized study.PATIENT SAMPLEThis study included 23 patients undergoing TLIF with UPSF and 25 patients undergoing TLIF with BPSF.OUTCOME MEASURESClinical outcomes were evaluated by visual analog scale (VAS) for low back pain and leg pain and Oswestry Disability Index (ODI) score. Radiographic outcomes included foraminal height, disc space height, segmental lordosis, and final fusion rates.METHODSThe clinical and radiographic outcomes were compared between the UPSF and BPSF group. The postoperative improvements were evaluated in either group. Intraoperative data such as duration of operation and estimated blood loss were collected. This study was registered at clinicaltrials.gov.RESULTSAnalysis of the VAS and ODI scores showed significant improvements in clinical outcomes within each group. No significant differences between the 2 groups were noted in the improvements of the VAS and ODI scores. The mean operative duration and blood loss were significantly greater in the BPSF group than in the UPSF group. There were significant improvements in the height of the foramen and intervertebral space and segmental lordosis in both groups, while there was no significant difference between the groups in amount of the improvements. No significant difference was found in the final fusion rates.CONCLUSIONSTLIF is an appropriate procedure for LFS treatment. With balanced intervertebral support using a cage, UPSF could achieve similar and satisfactory effects on lumbar segmental stability and fusion compared to BPSF. The unilateral approach appears to be associated with slightly shorter operative time and less blood loss.  相似文献   

19.
The impact of adult scoliosis on pain, function and health-related quality of life (QOL) has not been clearly defined. A population-based study using widely applied screening tools could better reflect the impact of adult scoliosis. In this study, a visual analog pain scale assessment (VAS) for lumbar and leg pain, an Oswestry disability index (ODI) and a standard version of the Medical Outcome Study Short Form-36 (SF-36) questionnaire were sent by mail to 261 women of age 50 years and older, consecutively evaluated with dual-energy radiograph absorptiometry (DXA) scan images. 138 patients (32 with lumbar curves 10° or bigger) returned the questionnaires. Differences in lumbar VAS, leg VAS, ODI and SF-36 values between groups of patients with curves <10°, 10°–19° and ≥20° were evaluated. Correlation analyses of the Cobb angle, age and body mass index (BMI) with VAS, ODI and SF-36 values, and multivariate regression analysis were performed. Patients with curves <10°, 10°–19° and ≥20° had no significant differences in lumbar or leg VAS, ODI or SF-36 values. ODI values correlated with age and BMI; SF-36 values correlated with BMI only; lumbar and leg VAS values did not correlate with lumbar curvature, age or BMI. Regression disclosed that Cobb angle values did not influence ODI, SF-36 or VAS values. In postmenopausal women with mild and moderate lumbar curves, Cobb angle had no influence on pain, function and QOL; age and BMI had small effect.  相似文献   

20.
目的探讨经椎间孔入路经皮内窥镜下椎间盘切除术(PETD)治疗经椎间孔腰椎椎间融合术(TLIF)术后相邻节段退变(ASD)型腰椎椎间盘突出症的临床疗效。方法回顾性分析2012年12月—2014年12月同济大学附属第十人民医院脊柱外科行PETD治疗的28例TLIF术后相邻节段腰椎椎间盘突出患者的临床资料,记录手术时间,术中出血量,住院天数,术前、术后3个月、术后12个月及末次随访时腰部、下肢疼痛视觉模拟量表(VAS)评分及Oswestry功能障碍指数(ODI),末次随访时采用Mac Nab标准评价临床疗效。结果所有手术均顺利完成,手术时间为(74.0±8.8)min,手术出血量为(32.6±6.8)m L,住院天数为(2.68±1.06)d,随访时间为(25.1±3.4)个月。术后3个月、术后12个月、末次随访时腰痛和下肢痛VAS评分及ODI与术前相比均有改善,差异均有统计学意义(P0.05)。根据Mac Nab标准,末次随访时患者临床疗效优良率为89.3%。结论 PETD治疗TLIF术后ASD型腰椎椎间盘突出症能够取得较为满意的疗效。  相似文献   

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