Patient-Reported Outcomes and Patient-Reported Satisfaction After Surgical Treatment for Cervical Radiculopathy

Study Design: Retrospective cohort study. Objectives: It is estimated that 10 000 patients seek medical care due to cervical radiculopathy every year in Denmark. Although the natural course is usually favorable, around 20% undergo surgery for cervical degenerative disease every year in Denmark. We aim to evaluate the patient-reported results and satisfaction of anterior cervical decompression and fusion over a 5-year period from a single Danish center for spine surgery. Methods: This study is a retrospective study based on prospectively collected data from 318 consecutive patients treated with anterior cervical decompression and fusion over 1 to 3 levels. Data in the DaneSpine registry was collected pre- and postoperatively, and at 1 year after surgery. The outcome measures were Neck Disability Index (NDI), European Quality of Life 5D (EQ-5D), visual analogue score (VAS), and Short Form-36 Physical Component Summary (SF-36 PCS). Results: Of 318 cases enrolled, 272 (85.5%) had follow-up data available at a minimum 1-year postoperatively. The mean preoperative NDI was 40.0 and improved to 22.7. Mean EQ-5D was 0.50 and improved to 0.70, and mean VAS arm was 60.4 improved to 26.4. All improvements were statistically significant. A total of 74.3% were back to work 1 year after surgery. Achieving minimal clinically important difference (MCID) in VAS neck and SF-36 PCS was strongly correlated to patient satisfaction. Conclusion: Patients who undergo anterior cervical discectomy and fusion can expect improvement in their pain and disability, with 74.3% of patients reporting a positive change in health status after surgery.

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P.229 Epidemiology and Outcomes of Neck Pain Following Surgery for Degenerative Cervical Radiculopathy

Canadian Journal of Neurological Sciences / Journal Canadien des Sciences Neurologiques ◽

10.1017/cjn.2021.520 ◽

2021 ◽

Vol 48 (s3) ◽

pp. S86-S86

Author(s):

MA MacLean ◽

A Dakson ◽

F Xavier ◽

SD Christie ◽

C Investigators

Keyword(s):

Neck Pain ◽

Short Form ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Research Network ◽

Cervical Disc ◽

Cervical Disc Arthroplasty ◽

Arm Pain ◽

Composite Scale ◽

Neck Disability

Background: Many studies have demonstrated improved arm pain (AP) following surgery for degenerative cervical radiculopathy (DCR); however, axial neck pain (NP) is generally not felt to improve. The purpose of this study was to determine whether surgery for DCR improves NP. Methods: A ambispective cohort study of the Canadian Spine Outcomes Research Network (CSORN) registry for patients who received 1-level, 2-level, 3-level ADCF (anterior cervical discectomy and fusion) or cervical disc arthroplasty (CDA) for DCR. Outcomes: 12-month post-operative Visual Analogue Scale for NP (VAS-NP), Neck Disability Index (NDI), VAS for AP (VAS-AP), Short-Form Physical Health Composite Scale (SF36-PCS), and Mental Health Composite Scale (SF36-MCS). Results: We identified 603 patients with DCR. CDA patients were the youngest (ANOVA; p<0.001). Patients reported similar pre-operative AP, NP, disability, and health-related quality of life, regardless of procedure (ANOVA; all P>0.05). All procedures offered a statistically significant reduction in VAS-NP, VAS-AP, and NDI (ANOVA; all P<0.001). Mean change from baseline in NP, AP, and disability, were similar across procedures. At 12 months, mean reduction in VAS-AP, VAS-NP, and NDI exceeded minimal clinically important differences for nearly all procedures. Conclusions: Patients undergoing surgery for DCR can expect a clinically significant, approximate 50% reduction in NP, AP, and neck-related disability.

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Cervicalgia entre estudantes de medicina: uma realidade multifatorial

Revista da Faculdade de Ciências Médicas de Sorocaba ◽

10.23925/1984-4840.2019v21i2a3 ◽

2019 ◽

Vol 21 (2) ◽

pp. 55-58

Author(s):

Marcos Iae Sato ◽

Luiz Fernando Aguiar ◽

Melissa Nóbrega Vasques de Freitas ◽

Isabella Guerra ◽

José Eduardo Martinez

Keyword(s):

Short Form ◽

Neck Disability Index ◽

Sao Paulo ◽

Medical Outcome Study ◽

Outcome Study ◽

Medical Outcome ◽

Short Form 36 ◽

Sf 36 ◽

Neck Disability ◽

De Medicina

Introdução: A cervicalgia afeta cerca de 50% da população. Predomina em mulheres e se relaciona a esforços repetitivos e má postura. O tempo de estudos e a utilização de livros, computadores e tablets pode gerar posturas inadequadas que podem causar cervicalgia. Objetivo: Conhecer a prevalência dessa afecção nos alunos de medicina da Pontifícia Universidade Católica de São Paulo (PUC-SP) e o respectivo perfil. Materiais e métodos: Foram avaliados cem estudantes de medicina da PUC-SP e aplicados questionários sobre dados demográficos, características clínicas, o Neck Disability Index (NDI) e o Medical Outcome Study Short Form 36 Survey (SF-36). Resultados: A prevalência de cervicalgia foi de 34%, com predomínio feminino. O quadro foi referido como crônico em 16%, enquanto 19% apresentaram apenas 1 episódio. Em relação ao NDI, observa-se que, entre aqueles com 17 a 19 anos, 3 não apresentaram incapacidade e 3 tinham incapacidade leve. De 20 a 22 anos, 6 não apresentaram incapacidade e 12, leve. De 23 a 25 anos, 2 não apresentaram incapacidade, 7 tinham incapacidade leve e 1, moderada. Acima de 26 anos, 1 apresentou incapacidade leve. Houve impacto na qualidade de vida nos domínios aspectos físicos, dor e vitalidade. A análise mostrou que os escores do SF-36 se correlacionam com os valores do NDI, com exceção do domínio aspectos sociais para ambos os sexos e os domínios vitalidade e saúde mental para o sexo masculino. Conclusão: Existe uma prevalência relevante de cervicalgia entre os alunos do curso de medicina da PUC-SP, gerando impacto na qualidade de vida.

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Percutaneous posterior cervical fusion with the DTRAX Facet System for single-level radiculopathy: results in 60 patients

Journal of Neurosurgery Spine ◽

10.3171/2012.12.spine12477 ◽

2013 ◽

Vol 18 (3) ◽

pp. 245-254 ◽

Cited By ~ 25

Author(s):

Bruce M. McCormack ◽

Rafael C. Bundoc ◽

Mario R. Ver ◽

Jose Manuel F. Ignacio ◽

Sigurd H. Berven ◽

...

Keyword(s):

Trabecular Bone ◽

Visual Analog Scale ◽

Short Form ◽

Translational Motion ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Ct Scans ◽

Cervical Lordosis ◽

Analog Scale ◽

Neck Disability

Object The authors present 1-year results in 60 patients with cervical radiculopathy due to spondylosis and stenosis that was treated with a bilateral percutaneous facet implant. The implant consists of a screw and washer that distracts and immobilizes the cervical facet for root decompression and fusion. Clinical and radiological results are analyzed. Methods Between 2009 and 2011, 60 patients were treated with the DTRAX Facet System in a multicenter prospective single-arm study. All patients had symptomatic clinical radiculopathy, and conservative management had failed. The majority of patients had multilevel radiographically confirmed disease. Only patients with single-level radiculopathy confirmed by history, physical examination, and in some cases confirmatory nerve blocks were included. Patients were assessed preoperatively with Neck Disability Index, visual analog scale, quality of life questionnaire (Short Form-12 version 2), CT scans, MRI, and dynamic radiographs. Surgery was percutaneous posterior bilateral facet implants consisting of a screw and expandable washer and iliac crest bone aspirate. Patients underwent postoperative assessments at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year with validated outcome questionnaires. Alterations of segmental and overall cervical lordosis, foraminal dimensions, device retention and fusion criteria were assessed for up to 1 year with CT reconstructions and radiographs. Fusion criteria were defined as bridging trabecular bone between the facets, translational motion < 2 mm, and angular motion < 5°. Results All patients were followed to 1 year postoperatively. Ages in this cohort ranged from 40 to 75 years, with a mean of 53 years. Forty-two patients were treated at C5–6, 8 at C6–7, 7 at C4–5, and 3 at C3–4. Fifty-six had bilateral implants; 4 had unilateral implants due to intraoperative facet fracture (2 patients) and inability to access the facet (2 patients). The Neck Disability Index, Short Form-12 version 2, and visual analog scale scores were significantly improved at 2 weeks and remained significantly improved up to 1 year. At the treated level, 93% had intrafacet bridging trabecular bone on CT scans, translational motion was < 2 mm in 100% and angular movement was < 5° in 83% at the 1-year follow-up. There was no significant change in overall cervical lordosis. There was a 1.6° loss of segmental lordosis at the treated level at 1 year that was significant. Foraminal width, volume, and posterior disc height was significantly increased at 6 months and returned to baseline levels at 1 year. There was no significant decrease in foraminal width and height at adjacent levels. There were no reoperations or surgery- or device-related complications, including implant failure or retained hardware. Conclusions Results indicate that the DTRAX Facet System is safe and effective for treatment of cervical radiculopathy.

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Does Neck Disability Index Correlate With 12-Month Satisfaction After Elective Surgery for Cervical Radiculopathy? Results From a National Spine Registry

Neurosurgery ◽

10.1093/neuros/nyz231 ◽

2019 ◽

Vol 86 (5) ◽

pp. 736-741 ◽

Cited By ~ 1

Author(s):

Inamullah Khan ◽

Ahilan Sivaganesan ◽

Kristin R Archer ◽

Mohamad Bydon ◽

Matthew J McGirt ◽

...

Keyword(s):

Patient Satisfaction ◽

Rating Scale ◽

Elective Surgery ◽

Multivariable Analysis ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Numeric Rating Scale ◽

Arm Pain ◽

Patient Reported ◽

Neck Disability

Abstract BACKGROUND Modern healthcare reforms focus on identifying and measuring the quality and value of care. Patient satisfaction is particularly important in the management of degenerative cervical radiculopathy (DCR) since it leads to significant neck pain and disability primarily affecting the patients’ quality of life. OBJECTIVE To determine the association of baseline and 12-mo Neck Disability Index (NDI) with patient satisfaction after elective surgery for DCR. METHODS The Quality Outcomes Database cervical module was queried for patients who underwent elective surgery for DCR. A multivariable proportional odds regression model was fitted with 12-mo satisfaction as the outcome. The covariates for this model included patients’ demographics, surgical characteristics, and baseline and 12-mo patient reported outcomes (PROs). Wald-statistics were calculated to determine the relative importance of each independent variable for 12-mo patient satisfaction. RESULTS The analysis included 2206 patients who underwent elective surgery for DCR. In multivariable analysis, after adjusting for baseline and surgery specific variables, the 12-mo NDI score showed the highest association with 12-mo satisfaction (Waldχ2-df = 99.17, 58.1% of total χ2). The level of satisfaction increases with decrease in 12-mo NDI score regardless of the baseline NDI score. CONCLUSION Our study identifies 12-mo NDI score as a very influential driver of 12-mo patient satisfaction after surgery for DCR. In addition, there are lesser contributions from other 12-mo PROs, baseline Numeric Rating Scale for arm pain and American Society of Anesthesiologists (ASA) grade. The baseline level of disability was found to be irrelevant to patients. They seemed to only value their current level of disability, compared to baseline, in rating satisfaction with surgical outcome.

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Συγκριτική μελέτη προγραμμάτων θεραπευτικής άσκησης σε ασθενείς με χρόνιο αυχενικό πόνο

10.12681/eadd/31436 ◽

2010 ◽

Author(s):

Βικτωρία Μισαηλίδου

Keyword(s):

Range Of Motion ◽

Health Survey ◽

Short Form ◽

Neck Disability Index ◽

Mcgill Pain Questionnaire ◽

Fear Avoidance ◽

Fear Avoidance Beliefs ◽

Sf 36 ◽

Neck Disability ◽

Fear Avoidance Beliefs Questionnaire

Σκοπός της παρούσας ερευνητικής μελέτης ήταν να διερευνηθεί η επίδραση τριών προγραμμάτων θεραπευτικής άσκησης στην αίσθηση πόνου, στη λειτουργική ικανότητα, στην αποφυγή λόγω φόβου, στην ποιότητα ζωής, στο εύρος κίνησης της αυχενικής μοίρας της Σ.Σ., στην αντοχή των καμπτήρων και εκτεινόντων μυών της αυχενικής μοίρας της Σ.Σ. και στην αναπνευστική λειτουργία σε ασθενείς με χρόνιο αυχενικό πόνο. Στην έρευνα έλαβαν μέρος 60 ασθενείς με χρόνιο αυχενικό πόνο οι οποίοι χωρίστηκαν σε τρεις ομάδες των 20 ατόμων. Στην πρώτη ομάδα έγινε αξιολόγηση και εφαρμόστηκε θεραπεία σύμφωνα με τις αρχές της μεθόδου McKenzie, στη δεύτερη ομάδα έγινε αξιολόγηση και εφαρμόστηκε θεραπεία με ένα εξελικτικό πρόγραμμα ασκήσεων διάτασης, ενδυνάμωσης, αντοχής και ιδιοδεκτικότητας και στην τρίτη ομάδα έγινε εφαρμογή αναπνευστικών ασκήσεων και τεχνικών χαλάρωσης. Όλοι οι συμμετέχοντες έλαβαν 12 συνεδρίες σε διάστημα 4-6 εβδομάδων ενώ οι μετρήσεις πραγματοποιήθηκαν πριν από την έναρξη και μετά την ολοκλήρωση της θεραπευτικής παρέμβασης. Για την αξιολόγηση της αίσθησης πόνου χρησιμοποιήθηκε το ερωτηματολόγιο McGill Pain Questionnaire – short form (SF-MPQ), της λειτουργικής ικανότητας το Neck Disability Index (NDI), της αποφυγής λόγω φόβου το Fear Avoidance Beliefs Questionnaire (FABQ) και για την ποιότητα ζωής το SF-36 Health Survey. Το εύρος κίνησης μετρήθηκε με ειδικό γωνιόμετρο κεφαλής Cervical Range of Motion Instrument(CROM), η αντοχή των καμπτήρων και εκτεινόντων μυών με χρονόμετρο χειρός και η αναπνευστική λειτουργία με φορητό σπιρόμετρο. Σύμφωνα με τα αποτελέσματα διαπιστώθηκε στατιστικά σημαντική βελτίωση στην αίσθηση πόνου, στη λειτουργική ικανότητα, στην αποφυγή λόγω φόβου, στην ποιότητα ζωής, στο εύρος κίνησης της αυχενικής μοίρας της Σ.Σ., στην αντοχή των καμπτήρων και εκτεινόντων μυών της αυχενικής μοίρας της Σ.Σ. και στην αναπνευστική λειτουργία μετά την εφαρμογή των θεραπευτικών προγραμμάτων και στις τρεις πειραματικές ομάδες με διαφοροποιήσεις στα ποσοστά βελτίωσης της κάθε ομάδας. Η ομάδα McKenzie, παρουσίασε τη μεγαλύτερη βελτίωση στον πόνο, στη λειτουργική ικανότητα , στην έκταση της αυχενικής μοίρας και στην αντοχή των καμπτήρων και εκτεινόντων μυών του αυχένα. Η ομάδα ενδυνάμωσης παρουσίασε τη μεγαλύτερη βελτίωση στην αποφυγή λόγω φόβου, στην ποιότητα ζωής, και στην κάμψη και στροφές της αυχενικής μοίρας ενώ η ομάδα των αναπνευστικών ασκήσεων παρουσίασε τη μεγαλύτερη βελτίωση στην αναπνευστική λειτουργία. Όλα τα θεραπευτικά προγράμματα είχαν θετικά αποτελέσματα αλλά κάποια κλινικά χαρακτηριστικά των ασθενών φαίνεται ότι ανταποκρίνονται καλύτερα σε συγκεκριμένους τύπους θεραπείας. Προτείνεται έρευνα που να ταξινομεί τους ασθενείς με χρόνιο αυχενικό πόνο σε υποομάδες με κοινά κλινικά χαρακτηριστικά με σκοπό να διερευνηθεί αν η ταξινόμηση αυτή βοηθάει στην βελτίωση του θεραπευτικού αποτελέσματος.

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Does Dynamic Anterior Plate Fixation Provide Adequate Stability for Traumatic Subaxial Cervical Spine Fractures at Mid-Term Follow-Up?

Journal of Clinical Medicine ◽

10.3390/jcm10061185 ◽

2021 ◽

Vol 10 (6) ◽

pp. 1185

Author(s):

Siegmund Lang ◽

Carsten Neumann ◽

Lasse Fiedler ◽

Volker Alt ◽

Markus Loibl ◽

...

Keyword(s):

Sagittal Alignment ◽

Short Form ◽

Trauma Surgery ◽

Neck Disability Index ◽

Patient Reported Outcome ◽

Cervical Fractures ◽

Sf 36 ◽

Patient Reported ◽

Bony Consolidation

Background: It remains questionable if the treatment of cervical fractures with dynamic plates in trauma surgery provides adequate stability for unstable fractures with disco-ligamentous injuries. The primary goal of this study was to assess the radiological and mid-term patient-reported outcome of traumatic subaxial cervical fractures treated with different plate systems. Patients and Methods: Patients, treated with anterior cervical discectomy and fusion (ACDF) between 2001 and 2015, using either a dynamic plate (DP: Mambo™, Ulrich, Germany) or a rigid locking plate (RP: CSLP™, Depuy Synthes, USA), were identified. For radiological evaluation, the sagittal alignment, the sagittal anterior translation and the bony consolidation were evaluated. After at least two years, the patient-reported outcome measures (PROM) were evaluated using the German Short-Form 36 (SF-36), Neck Disability Index (NDI) and the EuroQol in 5 Dimensions (EQ-5D) scores. Results: 33 patients met the inclusion criteria (DP: 13; RP:20). Twenty-six patients suffered from AO Type B or C fractures. Both the sagittal alignment and the sagittal translation could be sufficiently improved in both groups (p ≥ 0.05). No significant loss of reduction could be observed at the follow-up in both groups (p ≥ 0.05). Bony consolidation could be observed in 30 patients (DP: 12/13 (92%); RP: 18/20 (90%); (p ≥ 0.05)). In 20 patients, PROMs could be evaluated (follow-up: 71.2 ± 25.5 months). The whole cohort showed satisfactory PROM results (EQ-5D: 72.0 ± 4.9; SF-36 PCS: 41.9 ± 16.2, MCS: 45.4 ± 14.9; NDI: 11.0 ± 9.1). without significant differences between the DP and RP group (p ≥ 0.05) Conclusion: The dynamic plate concept provides enough stability without a difference in fusion rates in comparison to rigid locking plates in a population that mostly suffered fragile fractures.

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A Long-Term Control Study of the Treatment of Cervical Radiculopathy by Percutaneous Endoscopic Posterior Cervical Discectomy and Anterior Cervical Decompression, Bone Graft Fusion and Internal Fixation

10.21203/rs.3.rs-78852/v1 ◽

2020 ◽

Author(s):

Xiaodong Huang ◽

Weiheng Wang ◽

Qingxi Meng ◽

Jiangming Yu ◽

Xiaojian Ye

Keyword(s):

Clinical Symptoms ◽

Neck Disability Index ◽

Cervical Radiculopathy ◽

Clinical Results ◽

Cervical Discectomy ◽

Anterior Cervical Decompression ◽

Intermediate Outcomes ◽

Significant Difference ◽

Neck Disability

Abstract BackgroundCervical spondylotic radiculopathy (CSR) is very common all over the world. However, there are only a few reports about the efficacy of percutaneous endoscopic posterior cervical discectomy (PEPCD) in the treatment of CSR. Anterior cervical decompression and fusion (ACDF) and PEPCD which is a better way to treat CSR need further study.MethodsFrom January 2015 to December 2016. A retrospective study of 70 patients undergoing surgery for CSR (33 using PEPCD and 37 using ACDF). The intra-operative parameters, neck disability index (NDI), neck and arm visual analog scale (VAS) score were used to assessed clinical outcome. Radiological outcomes were assessed by measuring cervical 2-7 (C2-7) lordosis, disc height index (DHI), and degree of degenerative changes at the corresponding level.ResultsThe mean follow-up period was 48.5 month (36 –66 months). Two groups can significantly improve the clinical symptoms. There was no significant difference between the two groups in clinical results (VAS, NDI). Compared with preoperative, the lordosis of C2-7 increased significantly at the last follow-up. At the last follow-up, C2-7 lordosis in the ACDF group was significantly higher than that in the PEPCD group. In PEPCD, compared with preoperative, there was no significant difference in the DHI, but the degree of disc degeneration was significantly increased at the last follow-up.ConclusionFor patients with CSR, PEPCD had similar clinical early and intermediate outcomes when compared with ACDF, with the advantages of minimally invasive. PEPCD is a sufficient and safe supplement and alternative to conventional surgery.

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OP443 Evaluating The Value Of Endovascular Innovations For Aortic Valve Replacement Through Clinical Benefits, Patient-reported Outcomes And Resource Consumption.

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462321001069 ◽

2021 ◽

Vol 37 (S1) ◽

pp. 17-17

Author(s):

Eduardo Pinar ◽

Juan García de Lara ◽

José Hurtado ◽

Miguel Robles ◽

Gunnar Leithold ◽

...

Keyword(s):

High Risk ◽

Aortic Valve ◽

Short Form ◽

Systematic Evaluation ◽

Special Importance ◽

Economic Modelling ◽

Sf 36 ◽

Patient Reported ◽

Clinical Benefits ◽

Sapien 3

IntroductionThe use of most recent Transcatheter aortic valve implants (TAVI) in the treatment of symptomatic severe aortic stenosis (SAS) is evolving with expanded indications from inoperable/high-risk to intermediate and low risk patients. Consequently, TAVI outcomes must be monitored to highlight its value under real-world conditions. Our aim was to prospectively evaluate TAVI (SAPIEN 3) outcomes in terms of patient's health-related quality of life (HRQoL), clinical outcomes, and healthcare resource utilization (HRU).MethodsAn observational prospective study including all consecutive patients with SAS undergoing a transcatheter valve implantation with Edwards SAPIEN 3 valve (transfemoral access) was conducted in full accordance with clinical guidelines from the European Society of Cardiology. Patients were evaluated before the intervention (baseline), at discharge, and after one, six and twelve months from the implant. A thoughtful and systematic evaluation of patients’ HRQoL (EQ-5D 5L, the Short Form-36 Health Survey -SF-36- and the Kansas City Cardiomyopathy Questionnaire -KCCQ-), clinical endpoints (that is, cardiovascular mortality, and rates of stroke, major bleeding, myocardial infarction, and re-hospitalization), echocardiographic measurements, and HRU (that is, Length of stay-LOS- in ward/intensive care unit -ICU-) was implemented. Multivariate regression models were applied to test outcomes while controlling key risk factors (that is, patient’ severity at baseline).ResultsA total of seventy-six patients (fifty percent female, fifty-five percent of intermediate-high risk) with a mean age of 82.1 ± 4.78 years were included. Implant success was 97.34% and cardiovascular death was 2.6% at one year. Significant reductions in mean and maximum gradients were achieved and maintained during follow-up. Mean LOS in ward (5.2 ± 4.0days) and ICU (0.22 ± 0.64 days) were low. Statistically significant improvements were detected in the KCCQ overall summary scores, EQ-5D, and SF-36 (Physical component summary) - all adjusted - p < 0.05 - after the intervention.ConclusionsTAVI represents a safe and effective innovation for SAS with clinical benefits translated into significant improvements in terms of HRQoL. Besides, the low HRU provides new insights for health-economic modelling and the optimization of limited resources of special importance under current pandemic situation.

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Assessment of computer adaptive testing version of the Neuro-QOL for people with multiple sclerosis

Multiple Sclerosis Journal ◽

10.1177/1352458518810159 ◽

2018 ◽

Vol 25 (13) ◽

pp. 1791-1799 ◽

Cited By ~ 1

Author(s):

Brian C Healy ◽

Jonathan Zurawski ◽

Cindy T Gonzalez ◽

Tanuja Chitnis ◽

Howard L Weiner ◽

...

Keyword(s):

Multiple Sclerosis ◽

Outcome Measures ◽

Computerized Adaptive Testing ◽

Short Form ◽

Patient Reported Outcome Measures ◽

Adaptive Testing ◽

Patient Reported Outcome ◽

Longitudinal Change ◽

Sf 36 ◽

Patient Reported

Background: To date, the computerized adaptive testing (CAT) version of the Neuro-quality of life (QOL) has not been assessed in a large sample of people with multiple sclerosis (MS). Objective: The aim of this study was to assess the associations between the CAT version of Neuro-QOL and other clinical and patient-reported outcome measures. Methods: Subjects ( n = 364) enrolled in SysteMS completed the CAT version of the Neuro-QOL and the 36-Item Short Form Survey (SF-36) within 4 weeks of a clinical exam that included the Multiple Sclerosis Functional Composite-4 (MSFC-4). The correlations between the Neuro-QOL domains and the MSFC-4 subscores and the SF-36 scores were calculated. The changes over time in the Neuro-QOL and other measures were also examined. Results: The lower extremity functioning score of the Neuro-QOL showed the highest correlations with MSFC-4 components including Timed 25-Foot Walk, 9-Hole Peg Test, and cognitive score. The expected domains of the Neuro-QOL showed high correlations with the SF-36 subscores, and some Neuro-QOL domains were associated with many SF-36 subscores. There was limited longitudinal change on the Neuro-QOL domains over 12 months, and the change was not associated with change on other measures. Conclusion: The CAT version of the Neuro-QOL shows many of the expected associations with clinical and patient-reported outcome measures.

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PATIENT-REPORTED OUTCOMES AND DISABILITY IN MULTIPLE SCLEROSIS

Journal of Neurology Neurosurgery & Psychiatry ◽

10.1136/jnnp-2015-312379.127 ◽

2015 ◽

Vol 86 (11) ◽

pp. e4.32-e4

Author(s):

Neil Scolding ◽

Hongwei Wang ◽

Yan Liu ◽

Lawrence Steinman

Keyword(s):

Multiple Sclerosis ◽

Patient Reported Outcomes ◽

Short Form ◽

Minimum Important Difference ◽

Point Change ◽

Clinical Difference ◽

Sf 36 ◽

Patient Reported ◽

Edss Score ◽

Multiple Sclerosis Patients

In the 2-year, phase 3 CARE-MS II study (NCT00548405), alemtuzumab demonstrated superior clinical and patient-reported outcomes (PROs) over subcutaneous interferon beta-1a in relapsing-remitting multiple sclerosis patients who had inadequate efficacy response to prior therapy. To further evaluate the relationship between PROs and disability, Short-Form 36-Item (SF-36) survey physical component summary (PCS) and mental component summary (MCS), and Functional Assessment of Multiple Sclerosis (FAMS) scores were analysed against Expanded Disability Status Scale (EDSS) outcomes, adjusted for baseline characteristics and randomisation arm. A 1.0-point difference in baseline EDSS score was associated with 2.0-point PCS, 0.8-point MCS, and 4.0-point FAMS worsening over 12 months (all P<0.001). A 1.0-point annualised EDSS score worsening corresponded to a 2.2-point PCS, 1.6-point MCS, and 6.0-point FAMS worsening (all P<0.001). For baseline EDSS score <4.0, 1.0-point annualised worsening was associated with 7.2-point FAMS and 2.0-point MCS worsening (both P<0.001). For baseline EDSS score ≥4.0, 1.0-point worsening corresponded to worsening on FAMS (2.4 points; P=0.04), but not MCS (P=0.82). Given that a half-point EDSS change is considered the minimum reliably measurable clinical difference, a 1.0-point change in SF-36 PCS and MCS or 3.0-point change in FAMS may represent a minimum important difference in PRO for multiple sclerosis patients.

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