Could Less Be More When Assessing Patient-Rated Outcome in Spinal Stenosis?

Mannion, Anne F.; Fekete, Tamás; Wertli, Maria M.; Mattle, Michèle; Nauer, Selina; Kleinstück, Frank; Jeszenszky, Dezsö; Haschtmann, Daniel; Becker, Hans‐Jürgen; Porchet, François

doi:10.1097/brs.0000000000000751

Cited by 15 publications

(15 citation statements)

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“…As for other metrics developed for determining a clinically relevant outcome following treatment (i.e., MCID [8], (MIC) [27], a substantial clinical benefit [11] and a satisfactory symptom state [28]), it is essential to recognize that the thresholds from the present study cannot be directly applied to comparisons of mean outcome scores between groups [12, 13, 17, 43]. The thresholds are developed to determine whether an individual has achieved an important preoperative to postoperative benefit/improvement and should be used in the same context when comparing treatment effects [13].…”

Section: Discussionmentioning

confidence: 99%

“…The method used in the present study is described in detail and advocated by the ‘IMMPACT Recommendation’ [12], and is the most frequently used method for determining thresholds for clinical importance [17, 18, 25–28]. Furthermore, according to US FDA-recommended methodology for defining thresholds for PROMs, the GPE scale is considered a suitable anchor [29].…”

Section: Discussionmentioning

confidence: 99%

“…Receiver Operating Characteristic (ROC) analyses were evaluated to explore how accurately ‘success’ assessed by a single question on the Global Perceived Effect (GPE) scale [23] would be reflected in the PROMs. Despite limited evidence for the validity of the GPE scale [12, 24], it is widely used [17, 18, 25–28] and recommended [12, 29] in such analyses. For each PROM three alternative response parameters were evaluated: the follow-up score, the change score and the percentage change score.…”

Section: Introductionmentioning

confidence: 99%

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Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Austevoll

Gjestad

Grotle

et al. 2019

BMC Musculoskelet Disord

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BackgroundAssessment of outcomes for spinal surgeries is challenging, and an ideal measurement that reflects all aspects of importance for the patients does not exist. Oswestry Disability Index (ODI), EuroQol (EQ-5D) and Numeric Rating Scales (NRS) for leg pain and for back pain are commonly used patients reported outcome measurements (PROMs). Reporting the proportion of individuals with an outcome of clinical importance is recommended. Knowledge of the ability of PROMs to identify clearly improved patients is essential. The purpose of this study was to search cut-off criteria for PROMs that best reflect an improvement considered by the patients to be of clinical importance.MethodsThe Global Perceived Effect scale was utilized to evaluate a clinically important outcome 12 months after surgery. The cut-offs for the PROMs that most accurately distinguish those who reported ‘completely recovered’ or ‘much improved’ from those who reported ‘slightly improved’, unchanged’, ‘slightly worse’, ‘much worse’, or ‘worse than ever’ were estimated. For each PROM, we evaluated three candidate response parameters: the (raw) follow-up score, the (numerical) change score, and the percentage change score.ResultsWe analysed 3859 patients with Lumbar Spinal Stenosis [(LSS); mean age 66; female gender 50%] and 617 patients with Lumbar Degenerative Spondylolisthesis [(LDS); mean age 67; 72% female gender]. The accuracy of identifying ‘completely recovered’ and ‘much better’ patients was generally high, but lower for EQ-5D than for the other PROMs. For all PROMs the accuracy was lower for the change score than for the follow-up score and the percentage change score, especially among patients with low and high PROM scores at baseline.The optimal threshold for a clinically important outcome was ≤24 for ODI, ≥0.69 for EQ-5D, ≤3 for NRS leg pain, and ≤ 4 for NRS back pain, and, for the percentage change score, ≥30% for ODI, ≥40% for NRS leg pain, and ≥ 33% for NRS back pain. The estimated cut-offs were similar for LSS and for LDS.ConclusionFor estimating a ‘success’ rate assessed by a PROM, we recommend using the follow-up score or the percentage change score. These scores reflected a clinically important outcome better than the change score.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Austevoll

Gjestad

Grotle

et al. 2019

BMC Musculoskelet Disord

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“…2,19 The multidimensional Core Outcome Measures Index (COMI) 12 is a very brief, patient-rated outcome instrument that measures pain, function, symptom-specific well-being, quality of life, and work/social disability associated with disorders of the spine, but without being specific to any one spinal condition. Despite its more "generic" nature, it has proven to be as valid and responsive as disease-specific instruments, such as the Swiss Spinal Stenosis questionnaire 10 and the Scoliosis Research Society-22 questionnaire 12 when used to assess outcomes for their respective spinal disorders.…”

mentioning

confidence: 99%

Assessment of outcome in patients undergoing surgery for intradural spinal tumor using the multidimensional patient-rated Core Outcome Measures Index and the modified McCormick Scale

Bellut

Burkhardt

Mannion

et al. 2015

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OBJECT The aim of this study was to evaluate outcome in patients undergoing surgical treatment for intradural spinal tumor using a patient-oriented, self-rated, outcome instrument and a physician-based disease-specific instrument. METHODS Prospectively collected data from 63 patients with intradural spinal tumor were analyzed in relation to scores on the multidimensional patient-rated Core Outcome Measures Index (COMI) and the physician-rated modified McCormick Scale, before and at 3 and 12 months after surgery. RESULTS There was no statistically significant difference between the scores on the modified McCormick Scale preoperatively and at the 3-month follow-up, though there was a trend for improvement (p = 0.073); however, comparisons between the scores determined preoperatively and at the 12-month follow-up, as well as 3- versus 12-month follow-ups, showed a statistically significant improvement in each case (p < 0.004). The COMI scores for axial pain, peripheral pain, and back-related function showed a significant reduction (p < 0.001) from before surgery to 3 months after surgery, and thereafter showed no further change (p > 0.05) up to 12 months postoperatively. In contrast, the overall COMI score, “worst pain,” quality of life, and social disability not only showed a significant reduction from before surgery to 3 months after surgery (p < 0.001), but also a further significant reduction up to 12 months postoperatively (p < 0.001). The scores for work disability showed no significant improvement from before surgery to the 3-month follow-up (p > 0.05), but did show a significant improvement (p = 0.011) from 3 months to 12 months after surgery. At the 3- and 12-month follow-ups, 85.2% and 83.9% of patients, respectively, declared that the surgical procedure had helped/helped a lot; 95.1% and 95.2%, respectively, declared that they were satisfied/very satisfied with their care. CONCLUSIONS COMI is a feasible tool to use in the evaluation of baseline symptoms and outcome in patients undergoing surgery for intradural spinal tumor. COMI was able to detect changes in outcome at 3 months after surgery (before changes were apparent on the modified McCormick Scale) and on later postoperative follow-up. The COMI subdomains are valuable for monitoring the patient’s reintegration into society and the work environment. The addition of an item that specifically covers neurological deficits may further increase the value of COMI in patients with spinal tumors.

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“…The single most important pillar for the advanced state-of-the-art treatment of spine-related problems is the better understanding of spine biomechanics [6]. It is now standard practice that evaluation of treatment outcomes be patient centered; where outcomes of interest reflect factors important to the patient such as, adequate pain control, quality of life and functionality [7]. For spine outcome assessment, quality of life tools and patient perspective instruments are being increasingly developed and used [8].…”

Section: Background and Study Objectivesmentioning

confidence: 99%

Long-Term Systematic Outcome Assessment of Patients Following Spine Surgery in Rwanda: The Use of Patient Reported Outcome Tools

Nshuti¹,

Guterman²,

Hakizimana³

et al. 2020

NNB

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Background: We conducted a systematic evaluation of neurological, functional, quality of life and pain outcomes of patients who underwent spine surgery in our neurosurgery unit using patient reported outcome (PRO) assessment tools. Methods: The study was performed by assessing outcome of all the patients who underwent spine surgery at our department in a cross-sectional fashion using a 5-year operative database. This was an all-inclusive spine outcome study with 2 main groups; a trauma group composed of spinal cord injured patients and a non-trauma group composed of patients with spinal degenerative diseases, spinal tumors, deformity, infection, and vascular malformations. Results: Our analysis included 197 patients who met inclusion criteria for the study. The overall study population was mainly dominated by spinal cord injured patients and spinal degenerative disease patients; 34 % and 60.9 % respectively. The average age was 42 years (range: 15-78 years) with patients in the trauma group being substantially younger than the rest of the cohort. Eighty five percent of trauma patients presented with spinal cord injury causing neurological deficit, of which 58% had no preservation of motor function below the level of injury; ASIA IS A and B (35.8% and 22% respectively). Additionally, 68% of patients in the non-trauma group underwent surgery with severe disability. Overall, 60% of all trauma patients showed improvement of their neurological status as per ASIA IS. Of note, 40% of patients with preoperative ASIA IS B and 8% of patients with preoperative ASIA IS A gained full neurological recovery postoperatively (ASIA IS E). Using the Core outcome measurement Index (COMI) from patient’s perspective, 78.6% of patients reported to have no pain significant enough to make them stop their normal daily activities. Rate of overall return to work (RTW) in the non-trauma group was 77% with 52% of patients being fully functional without condition-related work interruptions. Conclusion: Careful selection of patients for surgery is key for good outcome of patients undergoing spine surgery. In contradiction to most other patients’ groups, patients with severe disability with spinal degenerative conditions might benefit most from surgery. Postoperative outcome of spinal cord injured patients with severe neurological deficits might be better than commonly believed. Controlled prospective data is likely to draw stronger conclusions.

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Could Less Be More When Assessing Patient-Rated Outcome in Spinal Stenosis?

Cited by 15 publications

References 40 publications

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Follow-up score, change score or percentage change score for determining clinical important outcome following surgery? An observational study from the Norwegian registry for Spine surgery evaluating patient reported outcome measures in lumbar spinal stenosis and lumbar degenerative spondylolisthesis

Assessment of outcome in patients undergoing surgery for intradural spinal tumor using the multidimensional patient-rated Core Outcome Measures Index and the modified McCormick Scale

Long-Term Systematic Outcome Assessment of Patients Following Spine Surgery in Rwanda: The Use of Patient Reported Outcome Tools

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