Defining Substantial Clinical Benefit Following Lumbar Spine Arthrodesis

Glassman, Steven D.; Copay, Anne G.; Berven, Sigurd; Polly, David W.; Subach, Brian R.; Carreon, Leah Y.

doi:10.2106/jbjs.g.01095

Cited by 346 publications

(246 citation statements)

References 18 publications

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“…Our data differ from other studies, since we not only measured the pain, but also determined the function and QOL. It is noteworthy that our study also shows that not only the differences in the VAS, ODI and SF-36 scores between the groups with curves \10°, 10°-19°and C20°d o not reach statistical significance, but also the median values of the three groups do not reach a minimal clinically important difference either [17,18]. This is important ,since a potential pitfall in evaluating pain, disability and QOL is considering only the statistical differences in outcome scores but not the clinical relevance of those differences.…”

Section: Discussioncontrasting

confidence: 61%

The impact of lumbar scoliosis on pain, function and health-related quality of life in postmenopausal women

et al. 2011

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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 C20°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 C20°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.

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Section: Discussioncontrasting

confidence: 61%

The impact of lumbar scoliosis on pain, function and health-related quality of life in postmenopausal women

et al. 2011

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“…A recent review proposed an MIC cutoff for the ODI of ten points, or 30% improvement from baseline [8]. Several studies have identified MIC cutoffs for the NRS back pain and leg pain from 2 to 2.5 [8,9]. In addition, cutoffs for substantial clinical improvements, such as ''success'' after lumbar disc surgery, have been reported both for the ODI (20), NRS back pain (2.5), NRS leg pain (3.5), and EQ-5D (0.3) [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…Several studies have identified MIC cutoffs for the NRS back pain and leg pain from 2 to 2.5 [8,9]. In addition, cutoffs for substantial clinical improvements, such as ''success'' after lumbar disc surgery, have been reported both for the ODI (20), NRS back pain (2.5), NRS leg pain (3.5), and EQ-5D (0.3) [9][10][11]. A large proportion of the patients are difficult to classify as either improved, unchanged, or worse after surgery [12].…”

Section: Introductionmentioning

confidence: 99%

Criteria for failure and worsening after surgery for lumbar disc herniation: a multicenter observational study based on data from the Norwegian Registry for Spine Surgery

et al. 2017

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“…It was originally described for patients who were surgically treated for lumbar degenerative disease and defined as clinical improvement that represented a substantial clinical benefit after treatment [3]. The method was similar to some of those used for constructing MCID [2].…”

Section: Introductionmentioning

confidence: 99%

“…The method was similar to some of those used for constructing MCID [2]. The patients rated their situation compared to the situation 1 year before [3].…”

Section: Introductionmentioning

confidence: 99%

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

et al. 2017

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Purpose It is difficult for clinicians to inform patients about the success rate of a treatment as a cervical anterior discectomy procedure. Ideally, a proportion of good outcome as rated by patients is known. Patient-reported outcome measurements are helpful. The purpose is to relate the difference in Neck Disability Index (NDI) after a cervical anterior discectomy procedure for single level cervical degenerative disc disease with the patients' rating of their actual clinical situation after long-term follow-up to define the substantial clinical benefit (SCB). Methods After completion of the NDI, patients who were surgically treated for cervical single level degenerative disease were asked to complete a five-item Likert scale to rate their clinical situation. After dichotomisation of the outcome in good versus less than good, a cut-off value was defined by determining the value of the difference of NDI with the highest specificity and sensitivity. Funding was not obtained.Results SCB for NDI after surgery for cervical single level degenerative disease should be set at ten with area under the curve (AUC) of 0.71 for sensitivity as well specificity. Conclusions The goal for each treatment is a good outcome. While comparing treatments for cervical degenerative disc disease only those with an SCB of ten will be relevant for the patient, as patients who achieved this difference in NDI rated their actual situation at long-term follow-up as good.

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Defining Substantial Clinical Benefit Following Lumbar Spine Arthrodesis

Abstract: We believe that thresholds of substantial clinical benefit for commonly used health-related quality-of-life measures following lumbar spine arthrodesis are important as they describe a magnitude of change that the patient recognizes as a major improvement.

Cited by 346 publications

References 18 publications

The impact of lumbar scoliosis on pain, function and health-related quality of life in postmenopausal women

The impact of lumbar scoliosis on pain, function and health-related quality of life in postmenopausal women

Criteria for failure and worsening after surgery for lumbar disc herniation: a multicenter observational study based on data from the Norwegian Registry for Spine Surgery

Substantial clinical benefit for Neck Disability Index revisited: establishing the goal for treatment?

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