Health-related quality of life in patients with surgically treated lumbar disc herniation

The Spine Journal, 2007

BACKGROUND CONTENT: There are currently a number of generic and disease-specific instruments for assessing complaints of low back pain (LBP). None provide the comprehensive coverage of the wide range of factors that are considered essential in evaluating treatment outcomes. PURPOSE: To develop and evaluate the psychometric properties of a comprehensive, diseasespecific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints. STUDY DESIGN: A clinical-cohort study of a large, convenience sample of LBP patients. METHODS: We have developed a comprehensive, disease-specific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints. A large group of patients who sought treatment for LBP (n52539) completed the Lumbar Spine Outcomes Questionnaire (LSOQ) before treatment, and at 12 and 24 months after treatment. For each subject and for each evaluation period, scores on six composite measures were derived from the subjects' responses to the questionnaire: a LBP severity score, a leg pain severity score, a functional disability score, a psychological distress score, a physical symptoms score, and a health-care utilization score. These scores were used to evaluate the reliability, validity, and responsiveness of the questionnaire. RESULTS: Test-retest reliability of the LSOQ was evaluated by correlating the subject's 12-month scores on each composite measure with the corresponding 24-month scores. Intraclass coefficients of correlation were used. The obtained coefficients of correlation [(a) LBP severity, 0.87; (b) leg pain severity, 0.85; (c) functional disability, 0.87; (d) psychological distress, 0.88; (e) physical symptoms other than pain, 0.82; and (f) health-care utilization, 0.76] indicate good test-retest reliability for the LSOQ. Construct validity was evaluated by correlating scores on the composite measures derived from the LSOQ with scores on measures of the same constructs derived from the Oswestry Low Back Pain Disability Questionnaire and the Short Form 36-Item Health Survey. The coefficients of correlation were relatively high (mostly between .7 and .9), indicating good construct validity. Construct validity was also evaluated by comparing the scores of groups of subjects who were known to differ or not to differ on the composite measures, using multivariate analyses of variance. Significant multivariate and univariate differences were obtained between groups who were expected to differ (ie, surgically and nonsurgically treated patients). No significant differences were found for groups who were not expected to differ (ie, patients with similar diagnosis, but different surgical treatments). Responsiveness was assessed by evaluating differences in the 24-month change scores between improved and unimproved subjects. Large and significant differences were obtained between improved and unimproved subjects for all composite measures derived from the LSOQ. The observed effect sizes ranged from .68 to 1.17 indicating that the LSOQ is highly responsive.

Global Spine Journal

Study Design: A single-center, retrospective cohort study. Objective: To predict patient-reported outcomes (PROs) using preoperative health-related quality-of-life (HRQoL) scores by quantifying the correlation between them, so as to aid selection of surgical candidates and preoperative counselling. Methods: All patients who underwent single-level elective lumbar spine surgery over a 2-year period were divided into 3 diagnosis groups: spondylolisthesis, spinal stenosis, and disc herniation. Patient characteristics and health scores (Oswestry Low Back Pain and Disability Index [ODI], EQ-5D, and Short Form-36 version 2 [SF-36v2]) were collected at 6 and 24 months and compared between the 3 diagnosis groups. Multivariate modelling was performed to investigate the predictive value of each parameter, particularly preoperative ODI and EQ-5D, on postoperative ODI and EQ-5D scores for all the patients. Results: ODI and EQ-5D at 6 and 24 months improved significantly for all patients, especia...

Medicina, 2009

Objective. This prospective observational study of the Short-Form Health Survey (SF-36), Oswestry Disability Index, Lithuanian version of the McGill Pain Questionnaire, and Visual Analogue Scale (VAS) for pain was performed to evaluate their effectiveness in the additional preoperative screening of patients with disc herniation disease. Patients and methods. In the present study, we investigated a cohort of 100 patients with lumbar disc herniation causing low back pain and the second one of 100 patients with nonspecific low back pain by applying physical activity, pain scales and Short-Form 36 General Health Questionnaire. Results. The quantitative analysis of SF-36 domain scores showed the substantial differences in both examined (herniated and control) groups. In the present study, we estimated moderate but statistically significant (P<0.05) correlations between the bodily pain domain scores and assessment of back and leg pain on the VAS, as well as between the physical functio...

Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association, 2012

Lumbar disc hernia (LDH) is a common cause of low back pain and radicular leg pain. The Japanese Orthopedic Association (JOA) score is a very short instrument for measuring functionality and pain in these patients. This study aimed to translate and validate the JOA score for use in Iran. This was a prospective clinical validation study. Translation of the English version of the questionnaire was performed in accordance with published guidelines. A sample of patients with LDH was asked to respond to the questionnaire at two points in time--at preoperative and postoperative (6 months follow-up) assessments. To test reliability, the internal consistency was assessed by use of Cronbach's alpha coefficient. Validity was evaluated by use of known-groups comparison. A total of 117 patients with LDH were entered into the study. The mean age of patients was 45 (SD = 11) and Cronbach's alpha coefficients for the JOA score at the preoperative and postoperative assessments were 0.67 and...

The Journal of Bone and Joint Surgery. British volume, 2009

We investigated the pre-operative and one-year post-operative health-related quality of life (HRQoL) outcome by using a Euroqol (EQ-5D) questionnaire in 230 patients who underwent surgery for lumbar spinal stenosis. Data were obtained from the National Swedish Registry for operations on the lumbar spine between 2001 and 2002. We analysed the pre- and postoperative quality of life data, age, gender, smoking habits, pain and walking ability. The relative differences were compared to a Swedish EQ-5D population survey. The mean age of the patients was 66 years, and there were 123 females (53%). Before the operation 62 (27%) of the patients could walk more than 500 m. One year after the operation 150 (65%) were able to walk 500 m or more. The mean EQ-5D score improved from 0.36 to 0.64, and the HRQoL improved in 184 (80%) of the patients. However, they did not reach the level reported by a matched population sample (mean difference 0.18). Women had lower pre- and post-operative EQ-5D sco...

European Spine Journal, 2005

European Spine Journal, 2017

Purpose In clinical decision-making, it is crucial to discuss the probability of adverse outcomes with the patient. A large proportion of the outcomes are difficult to classify as either failure or success. Consequently, cutoff values in patient-reported outcome measures (PROMs) for ''failure'' and ''worsening'' are likely to be different from those of ''non-success''. The aim of this study was to identify dichotomous cutoffs for failure and worsening, 12 months after surgical treatment for lumbar disc herniation, in a large registry cohort. Methods A total of 6840 patients with lumbar disc herniation were operated and followed for 12 months, according to the standard protocol of the Norwegian Registry for Spine Surgery (NORspine). Patients reporting to be unchanged or worse on the Global Perceived Effectiveness (GPE) scale at 12-month follow-up were classified as ''failure'', and those considering themselves ''worse'' or ''worse than ever'' after surgery were classified as ''worsening''. These two dichotomous outcomes were used as anchors in analyses of receiver operating characteristics (ROC) to define cutoffs for failure and worsening on commonly used PROMs, namely, the Oswestry Disability Index (ODI), the EuroQuol 5D (EQ-5D), and Numerical Rating Scales (NRS) for back pain and leg pain. Results ''Failure'' after 12 months for each PROM, as an insufficient improvement from baseline, was (sensitivity and specificity): ODI change \13 (0.82, 0.82), ODI% change \33% (0.86, 0.86), ODI final raw score [25 (0.89, 0.81), NRS back-pain change\1.5 (0.74, 0.86), NRS backpain % change \24 (0.85, 0.81), NRS back-pain final raw score [5.5 (0.81, 0.87), NRS leg-pain change \1.5 (0.81, 0.76), NRS leg-pain % change \39 (0.86, 0.81), NRS legpain final raw score [4.5 (0.91, 0.85), EQ-5D change \0.10 (0.76, 0.83), and EQ-5D final raw score[0.63 (0.81, 0.85). Both a final raw score [48 for the ODI and an NRS [7.5 were indicators for ''worsening'' after 12 months, with acceptable accuracy. Conclusion The criteria with the highest accuracy for defining failure and worsening after surgery for lumbar disc herniation were an ODI percentage change score\33% for failure and a 12-month ODI raw score [48. These cutoffs can facilitate shared decision-making among doctors and patients, and improve quality assessment and comparison Electronic supplementary material The online version of this article (

Global Spine Journal

Study Design: Prospective multicenter cohort study. Objective: To investigate (1) the discriminative ability and cutoff estimates for success 12 months after surgery for lumbar disc herniation on the Oswestry Disability Index (ODI) raw score compared with a change and a percentage change score and (2) to what extent these clinical outcomes depend on the baseline disability. Methods: A total of 6840 patients operated for lumbar disc herniation from the Norwegian Registry for Spine Surgery (NORspine) were included. In receiver operating characteristic (ROC) curve analyses, a global perceived effect (GPE) scale (1-7) was used an external anchor. Success was defined as categories 1-2, “completely recovered” and “much better.” Cutoffs for success for subgroups with different preoperative disability were also estimated. Results: When defining success after surgery for lumbar disc herniation, the accuracy (sensitivity, specificity, area under the curve, 95% CI) for the ODI raw score (0.83,...

European Spine Journal, 2007

To study the characteristics and changes in the total Oswestry Disability Index (ODI) and in its ten component items in female and male patients preand post-surgery for lumbar disc herniation. Ninetyeight patients [mean (SD) age 43 (13), 61% males] undergoing lumbar disc herniation surgery were selected for this clinical 12-month follow-up. Subjective disability and back and leg pain were assessed by ODI version 1.0 and the visual analog scale. Pre-operatively females had a significantly higher mean (SD) total ODI [59(3)] than males [51(2)] (P = 0.030). Females were more disabled in the walking, sex life, social life and travelling items of the ODI compared to males. The total Oswestry decreased by 38 (95% CI -44 to -31) in females and by 34 (-39 to -30) in males at the 1-year follow-up. Most of the improvement (88% in females and 80% in males) occurred during the first 6 weeks; thereafter the changes were minor. In males the changes were greatest in pain, social life and travelling and in females in walking, social life and travelling. Internal consistency value of ODI was 0.88 (95% CI 0.82-0.91). Item analysis of the ODI showed that all the items except pain had high corrected item correlation. As recovery following lumbar disc surgery occurred to a great extent during the first 6 weeks, the early post-operative outcome appears to be quite a reliable indicator of the overall post-operative outcome over the 1-year follow-up. The ODI proved to capture a wide range of disability in these lumbar disc surgery patients, thereby supporting the future use of the index. The ''pain intensity'' component, which collects data on the use of painkillers in version 1.0 of the ODI did not support the item structure of the index in this study. The use of ODI version 2.0 might remove this problem.

Asian Spine Journal, 2016

To translate and culturally adapt an Iranian version of the Pain Sensitivity Questionnaire (PSQ) in Iran. Overview of Literature: Instruments measuring patient reported outcomes should satisfy certain psychometric properties. Methods: The PSQ was translated following cross-cultural adaptation guidelines. A total of 101 patients with lumbar disc herniation (LDH), and 39 healthy cases were included in the study. All participants completed the PSQ and the Pain Catastrophizing Scale (PCS). The internal consistency, test-retest reliability, known group comparison, criterion validity and item-scale correlations were assessed. Results: The mean age of participants was 51.7 years. Reliability, validity and correlation of PSQ and PCS showed satisfactory results. Cronbach's alpha coefficients were 0.81 for PSQ-total, 0.82 for PSQ-minor, and 0.82 for PSQ-moderate. The intraclass correlation coefficients value was 0.84 (0.616-0.932) indicating an excellent test-retest reliability. The instrument discriminated well between subgroups of patients who differed in a standard predictive measure of LDH surgery (the Finneson-Cooper score). Total PSQ were also significantly correlated with the total scores of the PCS, lending support to its good convergent validity. Additionally, the correlation of each item with its hypothesized domain on the PSQ indicated acceptable results, suggesting that the items had a substantial relationship with their own domains. Conclusions: The adapted Iranian PSQ is a valid and reliable questionnaire for the assessment of pain in patients with LDH.

The Spine Journal, 2008

BACKGROUND CONTEXT: The impact of lumbar spinal surgery is commonly evaluated with three patient-reported outcome measures: Oswestry Disability Index (ODI), the physical component summary (PCS) of the Short Form of the Medical Outcomes Study (SF-36), and pain scales. A minimum clinically important difference (MCID) is a threshold used to measure the effect of clinical treatments. Variable threshold values have been proposed as MCID for those instruments despite a lack of agreement on the optimal MCID calculation method. PURPOSE: This study has three purposes. First, to illustrate the range of values obtained by common anchor-based and distribution-based methods to calculate MCID. Second, to determine a statistically sound and clinically meaningful MCID for ODI, PCS, back pain scale, and leg pain scale in lumbar spine surgery patients. Third, to compare the discriminative ability of two anchors: a global health assessment and a rating of satisfaction with the results of the surgery. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: A total of 454 patients from a large database of surgeries performed by the Lumbar Spine Study Group with a 1-year follow-up on either ODI or PCS were included in the study. OUTCOME MEASURES: Preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item (HTI) of the SF-36, and Satisfaction with Results scales. METHODS: ODI, SF-36, and pain scales were administered before and 1 year after spinal surgery. Several candidate MCID calculation methods were applied to the data and the resulting values were compared. The HTI of the SF-36 was used as the anchor and compared with a second anchor (Satisfaction with Results scale). RESULTS: Potential MCID calculations yielded a range of values: fivefold for ODI, PCS, and leg pain, 10-fold for back pain. Threshold values obtained with the two anchors were very similar. CONCLUSIONS: The minimum detectable change (MDC) appears as a statistically and clinically appropriate MCID value. MCID values in this sample were 12.8 points for ODI, 4.9 points for PCS, 1.2 points for back pain, and 1.6 points for leg pain. Ó

Value in Health, 2009

The objective of this study was to investigate the interchangeability of the EuroQol 5D (EQ-5D) and the Short Form 6D (SF-6D) in individuals with long-lasting low back pain to guide the optimal choice of instrument and to inform decision-makers about any between-measure discrepancy, which require careful interpretation of the results of costutility evaluations. Methods: A cross-sectional study was conducted across 275 individuals who had spinal surgery on indication of chronic low back pain. EQ-5D and SF-6D were mailed to respondents for self-completion. Statistical analysis of between-measure agreement (using English weights) was based on Bland and Altman's limits of agreement and a series of linear regressions. Results: A moderate mean difference of 0.085 (SD 0.241) was found, but because it masked more severe bidirectional variation, the expected variation between observations of EQ-5D and SF-6D in future studies was estimated at 0.546. The EQ-5D's N3 term alone explained a factor of 0.79 of the variation in between-measure differences, while the explanatory value of adding variables of age, sex, diagnosis, previous surgery, and occupational status was basically zero. A final model including only dummy variables for the N3 term and five identified framing effects explained a factor of 0.86 of the variation in between-measure differences. Conclusions: Although the EQ-5D and the SF-6D are both psychometrically valid for generic outcome assessment in long-lasting low back pain, it appears that they cannot generally be used interchangeably for measurement of preference values. Sensitivity analysis examining the impact of between-measure discrepancy thus remains a necessary condition for the interpretation of the results of cost-utility evaluations. Keywords: EQ-5D, health-related quality of life, low back pain, SF-6D.

Global Spine Journal, 2019

Study Design: Longitudinal cohort study. Objectives: To investigate whether a cutoff point in leg pain intensity measured preoperatively or at early follow-up could identify patients at risk of poor outcomes in terms of disability at 1-year and 2-year follow-up after first-time lumbar discectomy, and to identify the characteristics associated with early postoperative leg pain intensity. Methods: From 2010 to 2013, 556 patients underwent lumbar discectomy. Leg pain intensity was measured preoperatively and at early postoperative follow-up and dichotomized according to an established cutoff point on a 0 to 100 visual analogue scale (mild <30, moderate/severe ≥30). The outcome measurement was Oswestry Disability Index (ODI). Generalized estimating equations modelling established the association between leg pain intensity and ODI. Characteristics associated with early postoperative leg pain intensity were identified using common hypothesis tests. Results: Moderate/severe leg pain int...

Clinical Orthopaedics and Related Research®, 2014

Background Lumbar disc herniation (LDH) is a common indication for lumbar spine surgery. The proportion of patients having a second surgery within 2 years varies in the literature between 0.5% and 24%, with recurrent herniation being the most common cause. Several studies have not found any relevant outcome differences between patients undergoing surgery for primary LDH and patients undergoing reoperation for a recurrent LDH, but these studies have limitations, including small sample size and retrospective design. Questions/purposes We (1) compared patient-reported outcomes between patients operated on for primary LDH and patients reoperated on for recurrent LDH within 1 year after index surgery and (2) determined risk factors for worse outcomes. Methods We obtained data from the Swedish National Spine Register, Swespine, where patient-reported outcomes are collected using mailed protocols at 1, 2, 5, and 10 years after surgery. Of the 13,562 patients identified who underwent LDH between January 2000 and May 2011, 13,305 (98%) underwent primary surgery for LDH and 257 (2%) underwent reoperation for a recurrent LDH within the first year. Patient-reported outcomes at 1 to 2 years were available for 8497 patients (63%), 8350 of 13,305 (63%) in the primary LDH group and 147 of 257 (57%) in the recurrent LDH group (p = 0.068). We compared leg and back pain (VAS: 0-100), function (Oswestry Disability Index [ODI]: 0-100), quality of life (EQ-5D: À0.59 to 1.0), patient satisfaction, and global assessment of leg pain between groups. We also analyzed rsik factors for worse global assessment and satisfaction. Each author certifies that he or she, or a member of his or her immediate family, has no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research 1 editors and board members are on file with the publication and can be viewed on request. Clinical Orthopaedics and Related Research 1 neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use. Each author certifies that his or her institution approved or waived approval for the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

Journal of Spine Surgery

Background: It is crucial to define if changes in patient-reported outcome (PRO) measure correspond to relevant clinical improvements. Aim of this study was to determine minimally clinically important differences (MCID) of the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) in patients with lumbar disc herniation (LDH) to assess surgical success. Methods: A total of 127 patients with LDH consecutively referred to our clinic were enrolled into this prospective study between March 2012 and August 2015. All participants completed the JOABPEQ and the Oswestry Disability Index (ODI) score before surgery, and at 1 year after surgery. Surgical success was defined based on clinical consensus of the team and be used as anchor. The MCID value of the JOABPEQ subscales were estimated using two anchor-based methods: (I) average change procedure (responsiveness); and (II) receiver operating characteristic (ROC) curve analysis. Results: The mean age of patients was 51.2±9.4 years, and there were 68 (53.5%) male. A total of 83.5% (106 cases) showed improvement based on the clinical consensus of the spine surgeon team at last follow-up. To assess surgical success, the two MCID calculation methods generated two optimal prediction thresholds