Publications by authors named "Miranda L van Hooff"

30 Publications

  • Page 1 of 1

The Scoliosis Research Society adult spinal deformity standard outcome set.

Spine Deform 2021 Apr 6. Epub 2021 Apr 6.

Department of Orthopedic Surgery, Norton Leatherman Spine Center, University of Louisville, Louisville, KY, USA.

Purpose: Symptomatic adult spinal deformity (ASD) with an extremely variable presentation with pain, with and without neurogenic leg pain, and/or disturbed sagittal and coronal balance, causes a significant societal burden of disease. It is an important consequence of the aging adult population, generating a plethora of spine-related interventions with variable treatment efficacy and consistently high costs. Recent years have witnessed more than a threefold increase in the prevalence and treatment of ASD, and further increases over the coming decades are expected with the growing elderly population worldwide. The ability to monitor and assess clinical outcomes has not kept pace with these developments. This paper addresses the pressing need to provide a set of common outcome metrics for this growing group of patients with back pain and other disabilities due to an adult spinal deformity.

Methods: The standard outcome set was created by a panel with global representation, using a thorough modified Delphi procedure. The three-tiered outcome hierarchy (Porter) was used as a framework to capture full cycle of care. The standardized language of the International Classification of Functioning, Disability and Health (WHO-ICF) was used.

Results: Consensus was reached on a core set of 25 WHO-ICF outcome domains ('What to measure'); on the accompanying globally available clinician and patient reported measurement instruments and definitions ('How to measure'), and on the timing of the measurements ('When to measure'). The current work has brought to light domains not routinely reported in the spinal literature (such as pulmonary function, return to work, social participation), and domains for which no adequate instruments have yet been identified (such as how to clinically quantify in routine practice lumbar spinal stenosis, neurogenic claudication, radicular pain, and loss of lower extremity motor function).

Conclusion: A standard outcome set was developed for patients undergoing treatment for adult spinal deformity using globally available outcome metrics. The current framework can be considered a reference for further work, and may provide a starting point for routine methodical and systematic monitoring of outcomes. Post-COVID e-health may accelerate the routine capture of these types of data.
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http://dx.doi.org/10.1007/s43390-021-00334-2DOI Listing
April 2021

Toward the Development of a Comprehensive Clinically Oriented Patient Profile: A Systematic Review of the Purpose, Characteristic, and Methodological Quality of Classification Systems of Adult Spinal Deformity.

Neurosurgery 2021 May;88(6):1065-1073

Department of Orthopaedic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.

Background: Existing adult spinal deformity (ASD) classification systems are based on radiological parameters but management of ASD patients requires a holistic approach. A comprehensive clinically oriented patient profile and classification of ASD that can guide decision-making and correlate with patient outcomes is lacking.

Objective: To perform a systematic review to determine the purpose, characteristic, and methodological quality of classification systems currently used in ASD.

Methods: A systematic literature search was conducted in MEDLINE, EMBASE, CINAHL, and Web of Science for literature published between January 2000 and October 2018. From the included studies, list of classification systems, their methodological measurement properties, and correlation with treatment outcomes were analyzed.

Results: Out of 4470 screened references, 163 were included, and 54 different classification systems for ASD were identified. The most commonly used was the Scoliosis Research Society-Schwab classification system. A total of 35 classifications were based on radiological parameters, and no correlation was found between any classification system levels with patient-related outcomes. Limited evidence of limited quality was available on methodological quality of the classification systems. For studies that reported the data, intraobserver and interobserver reliability were good (kappa = 0.8).

Conclusion: This systematic literature search revealed that current classification systems in clinical use neither include a comprehensive set of dimensions relevant to decision-making nor did they correlate with outcomes. A classification system comprising a core set of patient-related, radiological, and etiological characteristics relevant to the management of ASD is needed.
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http://dx.doi.org/10.1093/neuros/nyab023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8117436PMC
May 2021

Good results at 2-year follow-up of a custom-made triflange acetabular component for large acetabular defects and pelvic discontinuity: a prospective case series of 50 hips.

Acta Orthop 2021 Feb 15:1-7. Epub 2021 Feb 15.

Orthopaedic Department, Sint Maartenskliniek, Nijmegen.

Background and purpose - Custom triflange acetabular components (CTACs) are suggested as good solutions for large acetabular defects in revision total hip arthroplasty. However, high complication rates have been reported and most studies are of limited quality. This prospective study evaluates the performance of a CTAC in patients with large acetabular defects including pelvic discontinuity.Patients and methods - Prospectively collected data of 49 consecutive patients (50 hips), who underwent an acetabular revision with a CTAC were analyzed. Follow-up (FU) was 2 years. The median age of the patients was 68 years (41-89) and 41 were women. Primary outcomes were re-revision of the CTAC and differences between the modified Oxford Hip Score (mOHS) preoperatively and at 2-year follow-up. Secondary outcomes included several patient-reported outcomes (PROMs), radiological results, complications, and a comparison between hips with and without pelvic discontinuity (PD).Results - 1 patient (1 hip) was lost to the 2-year FU. No CTAC needed re-revision. The preoperative and 2-year FU mOHS were available in 40 hips and improved statistically significantly. All of the other secondary outcomes improved over time. 5 hips (of 45 with radiological 2-year FU) had loosening of screws. 8 hips had complications, including 3 persistent wound leakage, 3 pelvic fractures, and 1 dislocation. The mOHS and complication rate were similar in hips with and without PD.Interpretation - Reconstruction of large acetabular defects with and without PD with this CTAC showed good improvement in patient-reported daily functioning, high patient-reported satisfaction, few complications, and no re-revisions at 2-year FU.
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http://dx.doi.org/10.1080/17453674.2021.1885254DOI Listing
February 2021

Outcomes After Lumbar Disk Herniation Surgery in the Dutch Population.

Global Spine J 2021 Feb 12:2192568221991124. Epub 2021 Feb 12.

Department Medical Advice, Zilveren Kruis Health Insurance Company, Leusden, Netherlands.

Study Design: Retrospective cohort study.

Objective: There is only limited data on the outcome of primary surgery of lumbar disk herniation (LDH) in Dutch patients. The objective of this study is to describe undesirable outcomes after primary LDH.

Methods: The National Claims Database (Vektis) was searched for primary LDH operations performed from July 2015 until June 2016, for reoperations within 18 months, prescription of opioids between 6 to 12 months and nerve root block within 1 year. A combined outcome measure was also made. Group comparisons were analyzed with the Student's t-test.

Results: Primary LDH surgery was performed in 6895 patients in 70 hospitals. Weighted mean of reoperations was 7.3%, nerve root block 6.7% and opioid use 15.6%. In total, 23.0% of patients had one or more undesirable outcomes after surgery. The 95% CI interval exceeded the 50% incidence line for 14 out of 26 hospitals with less than 50 surgical interventions per year. Although the data suggested a volume effect on undesired outcomes, the t-tests between hospitals with volume thresholds of 100, 150 and 200 interventions per year did not support this ( values 0.078, 0.129, 0.114).

Conclusion: This unique nationwide claims-based study provides insight into patient-relevant undesirable outcomes such as reoperation, nerve root block and opioid use after LDH surgery. About a quarter of the patients had a serious complication in the first follow up year that prompted further medical treatment. There is a wide variation in complication rates between hospitals with a trend that supports concentration of LDH care.
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http://dx.doi.org/10.1177/2192568221991124DOI Listing
February 2021

No added value of 2-year radiographic follow-up of fusion surgery for adolescent idiopathic scoliosis.

Eur Spine J 2021 Mar 3;30(3):759-767. Epub 2021 Jan 3.

Department of Orthopedics, Sint Maartenskliniek, Nijmegen, The Netherlands.

Purpose: For fusion surgery in adolescent idiopathic scoliosis (AIS) consensus exists that a 2-year radiographic follow-up assessment is needed. This standard lacks empirical evidence. The purpose of this study was to investigate the radiographic follow-up after corrective surgery in AIS, from pre-until 2 years postoperative.

Methods: In this historical cohort study, 63 patients surgically treated for AIS, age ≤ 25 years, with 2-year radiographic follow-up, were enrolled. The primary outcome measure was the major Cobb angle. Secondary outcomes were coronal and sagittal spino-pelvic parameters, including proximal junction kyphosis (PJK) and distal adding-on. Change over time was analyzed using a repeated measures ANOVA.

Results: The major curve Cobb angle showed a statistically significant change for pre- to 1 year postoperative, but not for 1- to 2-year follow-up. Seven out of 63 patients did show a change exceeding the error of measurement (5°) from 1- to 2-year follow-up (range -8° to +7°), of whom 2 patients showed curve progression and 5 showed improvement. PJK or distal adding-on was not observed.

Conclusions: No statistically significant changes in major curve Cobb angle were found during postsurgical follow-up, or in adjacent non-fused segments. The findings of this study are not supportive for routine radiographs 2 years after fusion surgery in AIS patients.
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http://dx.doi.org/10.1007/s00586-020-06696-xDOI Listing
March 2021

Pulmonary function in patients with spinal deformity: have we been ignorant?

Acta Orthop 2020 10 3;91(5):503-505. Epub 2020 Jul 3.

Department of Orthopedics, Radboud University Medical Center, Nijmegen, The Netherlands.

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http://dx.doi.org/10.1080/17453674.2020.1786267DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8023902PMC
October 2020

Mechanical Stability of the Prodisc-C Vivo Cervical Disc Arthroplasty: A Preliminary, Observational Study Using Radiostereometric Analysis.

Global Spine J 2020 May 23;10(3):294-302. Epub 2019 May 23.

Sint Maartenskliniek, Nijmegen, the Netherlands.

Study Design: Prospective cohort study.

Objective: To investigate the primary stability of the Prodisc-C Vivo cervical disc arthroplasty with regard to the adjacent cervical vertebrae using radiostereometric analysis (RSA), and to monitor its clinical performance.

Methods: Sixteen patients with degenerative cervical disc disease were included. RSA radiographs were obtained at the first postoperative day, at 6 weeks, 3 months, and 6 months postoperatively. Migration (translation [mm]) of the superior and inferior implant components were measured with model-based RSA, expressed along the 3 orthogonal axes, and calculated as total translation. Clinical outcomes were Neck Disability Index, numeric rating scales for neck and arm pain, Likert-type scales for satisfaction, and adverse events. Range of motion was reported as C2-C7 flexion-extension mobility (ROM).

Results: At final follow-up, no significant increase over time in median total translation was found. One inferior and 3 superior components subsided but were asymptomatic. ROM remained stable and clinical outcomes improved over time. Although 3 patients were unsatisfied and 3 adverse events occurred, this was not related to translation of the components.

Conclusions: On a group level, both components of the Prodisc-C Vivo cervical disc arthroplasty remained stable over time and below the clinical threshold of 1 mm. Individual outliers for translation were not clinically relevant and probably related to settling of the components into the vertebral endplates. RSA allowed us to perform a preliminary but accurate study on the micromotion of a new cervical disc replacement in a small sample size, without putting large numbers of patients at risk.
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http://dx.doi.org/10.1177/2192568219850763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160805PMC
May 2020

The Natural History of Progression in Adult Spinal Deformity: A Radiographic Analysis.

Global Spine J 2020 May 1;10(3):272-279. Epub 2019 May 1.

Sint Maartenskliniek, Department of Orthopaedic Surgery, Nijmegen, the Netherlands.

Study Design: Historical cohort study.

Objective: To evaluate progression in the coronal and sagittal planes in nonsurgical patients with adult spinal deformity (ASD).

Methods: A retrospective analysis of nonsurgical ASD patients between 2005 and 2017 was performed. Magnitude of the coronal and sagittal planes were compared on the day of presentation and at most recent follow-up. Previous reported prognostic factors for progression in the coronal plane, including the direction of scoliosis, curve magnitude, and the position of the intercrest line (passing through L4 or L5 vertebra), were studied.

Results: Fifty-eight patients were included with a mean follow-up of 59.8 ± 34.5 months. Progression in the coronal plane was seen in 72% of patients. Mean Cobb angle on the day of presentation and most recent follow-up was 37.2 ± 14.6° and 40.8° ± 16.5°, respectively. No significant differences were found in curve progression in left- versus right-sided scoliosis (3.3 ± 7.1 vs 3.7 ± 5.4, = .81), Cobb angle <30° versus ≥30° (2.6 ± 5.0 vs 4.3 ± 6.5, = .30), or when the intercrest line passed through L4 rather than L5 vertebra (3.4 ± 5.0° vs 3.8 ± 7.1°, = .79). No significant differences were found in the sagittal plane between presentation and most recent follow-up.

Conclusions: This is the first study that describes progression in the coronal and sagittal planes in nonsurgical patients with ASD. Previous reported prognostic factors were not confirmed as truly relevant. Although progression appears to occur, large variation exists and these results may not be directly applicable to the individual patient.
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http://dx.doi.org/10.1177/2192568219845659DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160806PMC
May 2020

Effectiveness of surgery for sciatica with disc herniation is not substantially affected by differences in surgical incidences among three countries: results from the Danish, Swedish and Norwegian spine registries.

Eur Spine J 2019 11 29;28(11):2562-2571. Epub 2018 Sep 29.

Department of Orthopaedics, Karolinska University Hospital, Stockholm, Sweden.

Purpose: Yearly incidence of surgery for symptomatic lumbar disc herniation varies and is 29/100,000 in Sweden, 46/100,000 in Denmark and 58/100,000 in Norway. This variation was used to study whether differences in surgical incidence were associated with differences in preoperative patient characteristics as well as patient-reported outcomes.

Methods: Data from the national spine registers in Sweden, Denmark and Norway during 2011-2013 were pooled, and 9965 individuals, aged 18-65 years, of which 6468 had one-year follow-up data, were included in the study. Both absolute and case-mix-adjusted comparisons of the primary outcome Oswestry Disability Index (ODI) and the secondary outcomes EQ-5D-3L, and Numerical Rating Scale (NRS) for leg and back pain were performed. Case-mix adjustment was done for baseline age, sex, BMI, smoking, co-morbidity, duration of leg pain and preoperative value of the dependent variable.

Results: Mean improvement in the outcome variables exceeded previously described minimal clinical important change in all countries. Mean (95% CI) final scores of ODI were 18 (17-18), 19 (18-20) and 15 (15-16) in Sweden, Denmark and Norway, respectively. Corresponding results of EQ-5D-3L were 0.74 (0.73-0.75), 0.73 (0.72-0.75) and 0.75 (0.74-0.76). Results of NRS leg and back pain behaved similarly. Case-mix adjustment did not alter the findings substantially.

Conclusion: We found no clear association between incidence of surgery for lumbar disc herniation and preoperative patient characteristics as well as outcome, and the differences between the countries were lower than the minimal clinical important difference in all outcomes. These slides can be retrieved under Electronic Supplementary Material.
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http://dx.doi.org/10.1007/s00586-018-5768-9DOI Listing
November 2019

Can patient-reported profiles avoid unnecessary referral to a spine surgeon? An observational study to further develop the Nijmegen Decision Tool for Chronic Low Back Pain.

PLoS One 2018 19;13(9):e0203518. Epub 2018 Sep 19.

Department of Orthopaedic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands.

Introduction: Chronic Low Back Pain (CLBP) is a heterogeneous condition with lack of diagnostic clarity. Therapeutic interventions show small effects. To improve outcomes by targeting interventions it is recommended to develop a triage system to surgical and non-surgical treatments based on treatment outcomes. The objective of the current study was to develop and internally validate prognostic models based on pre-treatment patient-reported profiles that identify patients who either respond or do not respond to two frequently performed treatments (lumbar spine surgery and multidisciplinary pain management program).

Methods: A consecutive cohort study in a secondary referral spine center was performed. The study followed the recommendations of the PROGRESS framework and was registered in the Dutch Trial Register (NTR5946). Data of forty-seven potential pre-consultation (baseline) indicators predicting 'response' or 'non-response' at one-year follow-up for the two treatments were obtained to develop and validate four multivariable logistic regression models. The source population consisted of 3,410 referred CLBP-patients. Two treatment cohorts were defined: elective 'spine surgery' (n = 217 [6.4%]) and multidisciplinary bio-psychosocial 'pain management program' (n = 171 [5.0%]). Main inclusion criteria were age ≥18, CLBP (≥6 months), and not responding to primary care treatment. The primary outcome was functional ability: 'response' (Oswestry Disability Index [ODI] ≤22) and 'non-response' (ODI ≥41).

Results: Baseline indicators predictive of treatment outcome were: degree of disability (all models), ≥2 previous spine surgeries, psychosocial complaints, age (onset <20 or >50), and patient expectations of treatment outcomes. The explained variances were low for the models predicting response and non-response to pain management program (R2 respectively 23% and 26%) and modest for surgery (R2 30% and 39%). The overall performance was acceptable (c-index; 0.72-0.83), the model predicting non-response to surgery performed best (R2 = 39%; c-index = 0.83).

Conclusion: This study was the first to identify different patient-reported profiles that predict response to different treatments for CLBP. The model predicting 'non-response' to elective lumbar spine surgery performed remarkably well, suggesting that referrals of these patients to a spine surgeon could be avoided. After external validation, the patient-reported profiles could potentially enhance timely patient triage to the right secondary care specialist and improve decision-making between clinican and patient. This could lead to improved treatment outcomes, which results in a more efficient use of healthcare resources.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0203518PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6145570PMC
February 2019

Lumbar spinal stenosis: comparison of surgical practice variation and clinical outcome in three national spine registries.

Spine J 2019 01 21;19(1):41-49. Epub 2018 May 21.

The Norwegian Registry for Spine Surgery (NORspine), Northern Norway Regional Health Authority, Helse Nord RHF, Postboks 1445, 8038 Bodø, Norway; Department of Neurosurgery, University Hospital of Northern Norway, Breivika, 9038, Tromsø, Norway; Institute of Clinical Medicine, University of Tromsø The Arctic University of Norway, Hansine Hansens veg 18, 9037, Tromsø, Norway.

Background Context: Decompression surgery for lumbar spinal stenosis (LSS) is the most common spinal procedure in the elderly. To avoid persisting low back pain, adding arthrodesis has been recommended, especially if there is a coexisting degenerative spondylolisthesis. However, this strategy remains controversial, resulting in practice-based variation.

Purpose: The present study aimed to evaluate in a pragmatic study if surgical selection criteria and variation in use of arthrodesis in three Scandinavian countries can be linked to variation in treatment effectiveness.

Study Design: This is an observational study based on a combined cohort from the national spine registries of Norway, Sweden, and Denmark.

Patient Sample: Patients aged 50 and older operated during 2011-2013 for LSS were included.

Outcome Measures: Patient-Reported Outcome Measures (PROMs): Oswestry Disability Index (ODI) (primary outcome), Numeric Rating Scale (NRS) for leg pain and back pain, and health-related quality of life (Euro-Qol-5D) were reported. Analysis included case-mix adjustment. In addition, we report differences in hospital stay.

Methods: Analyses of baseline data were done by analysis of variance (ANOVA), chi-square, or logistic regression tests. The comparisons of the mean changes of PROMs at 1-year follow-up between the countries were done by ANOVA (crude) and analysis of covariance (case-mix adjustment).

Results: Out of 14,223 included patients, 10,890 (77%) responded at 1-year follow-up. Apart from fewer smokers in Sweden and higher comorbidity rate in Norway, baseline characteristics were similar. The rate of additional fusion surgery (patients without or with spondylolisthesis) was 11% (4%, 47%) in Norway, 21% (9%, 56%) in Sweden, and 28% (15%, 88%) in Denmark. At 1-year follow-up, the mean improvement for ODI (95% confidence interval) was 18 (17-18) in Norway, 17 (17-18) in Sweden, and 18 (17-19) in Denmark. Patients operated with arthrodesis had prolonged hospital stay.

Conclusions: Real-life data from three national spine registers showed similar indications for decompression surgery but significant differences in the use of concomitant arthrodesis in Scandinavia. Additional arthrodesis was not associated with better treatment effectiveness.
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http://dx.doi.org/10.1016/j.spinee.2018.05.028DOI Listing
January 2019

Decision support tools in low back pain.

Best Pract Res Clin Rheumatol 2016 12 5;30(6):1084-1097. Epub 2017 Aug 5.

Department of Epidemiology and Biostatistics, VU University Medical Centre, Amsterdam, The Netherlands; Department of Health Sciences, Faculty of Earth and Life Sciences, VU University, Amsterdam, The Netherlands.

Information from individual classification systems or clinical prediction rules that aim to facilitate stratified care in low back pain is important but often not comprehensive enough to be used to support clinical decision-making. The development and implementation of a clinically useful decision support tool (DST) that considering all key features is a challenging enterprise, requiring a multidisciplinary approach. Key features are inclusion of all relevant treatment options, patient characteristics, and benefits and harms and presentation as an accessible and easy to use toolkit. To be of clinical value, a DST should (1) be based on large numbers of high-quality data, allowing robust estimation of benefits and harms; (2) be presented using visually attractive and easy-to-use software; (3) be externally validated with a clinical beneficial impact established; and (4) include a procedure for regular updating and monitoring. As an illustration, we describe the development; presentation; and plans for further validation, implementation, and updating of the Nijmegen Decision Tool for Chronic Low Back Pain (NDT-CLBP).
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http://dx.doi.org/10.1016/j.berh.2017.07.002DOI Listing
December 2016

Defining a core outcome set for adolescent and young adult patients with a spinal deformity.

Acta Orthop 2017 Dec 15;88(6):612-618. Epub 2017 Sep 15.

a Department of Orthopedic Surgery , Radboud University Medical Center , Nijmegen , the Netherlands.

Background and purpose - Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods - From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results - Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "self-image", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation - We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective.
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http://dx.doi.org/10.1080/17453674.2017.1371371DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5694805PMC
December 2017

Which patient-reported factors predict referral to spinal surgery? A cohort study among 4987 chronic low back pain patients.

Eur Spine J 2017 11 30;26(11):2782-2788. Epub 2017 Jun 30.

Department of Health Sciences and EMGO+ Institute for Health and Care Research, Faculty of Earth and Life Sciences, VU University Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.

Purpose: It is unknown which chronic low back pain (CLBP) patients are typically referred to spinal surgery. The present study, therefore, aimed to explore which patient-reported factors are predictive of spinal surgery referral among CLBP patients.

Methods: CLBP patients were consecutively recruited from a Dutch orthopedic hospital specialized in spine care (n = 4987). The outcome of this study was referral to spinal surgery (yes/no), and was assessed using hospital records. Possible predictive factors were assessed using a screening questionnaire. A prediction model was constructed using logistic regression, with backwards selection and p < 0.10 for keeping variables in the model. The model was internally validated and evaluated using discrimination and calibration measures.

Results: Female gender, previous back surgery, high intensity leg pain, somatization, and positive treatment expectations increased the odds of being referred to spinal surgery, while being obese, having comorbidities, pain in the thoracic spine, increased walking distance, and consultation location decreased the odds. The model's fit was good (X  = 10.5; p = 0.23), its discriminative ability was poor (AUC = 0.671), and its explained variance was low (5.5%). A post hoc analysis indicated that consultation location was significantly associated with spinal surgery referral, even after correcting for case-mix variables.

Conclusion: Some patient-reported factors could be identified that are predictive of spinal surgery referral. Although the identified factors are known as common predictive factors of surgery outcome, they could only partly predict spinal surgery referral.
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http://dx.doi.org/10.1007/s00586-017-5201-9DOI Listing
November 2017

Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.

Eur Spine J 2017 08 22;26(8):2084-2093. Epub 2017 May 22.

Department of Orthopedics, Radboud University Medical Center, Huispost 611, 6500HB, Nijmegen, The Netherlands.

Purpose: Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD.

Methods: Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated.

Results: The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD.

Conclusions: Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.
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http://dx.doi.org/10.1007/s00586-017-5125-4DOI Listing
August 2017

Validity and Reproducibility of the STarT Back Tool (Dutch Version) in Patients With Low Back Pain in Primary Care Settings.

Phys Ther 2017 May;97(5):561-570

Department of General Practice, Erasmus MC.

Objective: The purpose of this study was to translate and to investigate the reliability and validity of the STarT Back screening tool (SBT) in the primary care setting among patients with nonspecific low back pain (LBP).

Design: The SBT was formally translated into Dutch following a multistep approach for forward and backward translation. General practitioners and physical therapists included patients with LBP.

Methods: Patients completed a baseline questionnaire and a follow-up at 3 days and 3 months. The construct validity was calculated with Pearson's correlation coefficient. The reproducibility was assessed using the quadratic weighted kappa and the specific agreement. Predictive validity was assessed using relative risk ratios for persisting disability at 3 months. Content validity was analyzed using floor and ceiling effects.

Results: In total, 184 patients were included; 52.2% were categorized in the "low-risk" subgroup, 38.0% "medium-risk," and 9.8% "high-risk." For the construct validity we found, as expected, a moderate to high Pearson's correlation for questions 3 to 9 and a low correlation for questions 1 and 2 with their respective reference questionnaires. The reproducibility had a quadratic weighted kappa of 0.65 and the specific agreement of 82.4% for "low-risk," 53.3% for "medium-risk," and 33.3% for "high-risk." For the predictive validity for persisting disability we found a relative risk ratio for "medium-risk" of 1.8 (95% confidence interval [CI]: 1.0-3.1) and 2.7 (95% CI: 1.4-4.9) for "high-risk" compared with "low-risk." For the content validity, we found that no floor and ceiling effects were present.

Limitations: There was a relatively small sample size for the retest reliability study. Patients were not compared between physical therapist and GP, as there were not enough patients in both groups. For practical reasons, the patients filled out the baseline questionnaire after receiving the first treatment/consultation; however, the questionnaire is intended to be filled in before the first consultation/treatment.

Conclusion: The SBT has been successfully translated into Dutch. The psychometric analysis showed acceptable results and, therefore, the SBT is a valid screening tool for patients with LBP in Dutch primary care.
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http://dx.doi.org/10.1093/ptj/pzx023DOI Listing
May 2017

Low sensitivity of implant sonication when screening for infection in revision surgery.

Acta Orthop 2017 Jun 13;88(3):294-299. Epub 2017 Mar 13.

a Department of Orthopaedic Surgery , Prosthetic Joint Infection Unit , Sint Maartenskliniek.

Background and purpose - Prosthetic-joint infection (PJI) is the most serious complication of arthroplasty, and accurate identification of a potentially responsible microorganism is essential for successful antibiotic treatment. We therefore determined the diagnostic accuracy of sonication and compared it with tissue culture as a screening tool in detecting prosthetic joint infection in revision arthroplasty. Patients and methods - 252 consecutive revision arthroplasty cases were enrolled. These cases were determined as being suspected or unsuspected of having infection according to standard criteria. Perioperatively, 6 periprosthetic interface tissue biopsies were obtained from each patient and the implants removed were sonicated. The sensitivity and specificity of periprosthetic tissue culture and sonication fluid cultures were determined. Results - Preoperatively, 75 revision cases were classified as having PJI (33 early and 42 late) and 177 were unsuspected of having infection. Compared with tissue culture, the sensitivity of the sonication fluid analysis was low: 0.47 (95% CI: 0.35-0.59) for sonication as compared to 0.68 (95% CI: 0.56-0.78) for tissue culture. The specificity of the sonication fluid analysis was higher than that for tissue culture: 0.99 (95% CI: 0.96-1.0) as compared to 0.80 (95% CI: 0.74-0.86). Interpretation - Sonication is a highly specific test for diagnosis of PJI. However, due to the low sensitivity, a negative sonication result does not rule out the presence of PJI. Thus, sonication is not of value for screening of microorganisms during revision surgery.
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http://dx.doi.org/10.1080/17453674.2017.1300021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5434598PMC
June 2017

Current Construct Options for Revision of Large Acetabular Defects: A Systematic Review.

JBJS Rev 2016 11;4(11)

1Department of Orthopaedic Surgery, Sint Maartenskliniek, Nijmegen, the Netherlands.

Background: Many treatment options are available for the revision of large acetabular defects. Debate continues as to which technique is most effective.

Methods: A systematic review was performed according to the Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines to evaluate the effectiveness of interventions for large acetabular defects. Quality assessment was performed next with use of 8 items of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for reports of observational studies. Large acetabular defects were defined as American Academy of Orthopaedic Surgeons (AAOS) type III or IV or Paprosky type 3A or 3B. Outcomes included re-revision, radiographic loosening, complications, and clinical outcomes.

Results: We found 7 different treatment options for large acetabular defects in 20 included studies: antiprotrusio cage (8 studies), Trabecular Metal (Zimmer) augment and shell (4 studies), bone impaction grafting with a metal mesh (2 studies), hemispherical implant with hook and flanges (2 studies), Trabecular Metal augment or structural allograft with cup (2 studies), cup-cage reconstruction (1 study), and custom-made triflange component (1 study).

Conclusions: Trabecular Metal augments and shells gave the most promising results in terms of the re-revision rate and radiographic loosening. Reconstruction with an antiprotrusio cage was the most frequently reported technique, with good results in a physically low-demand elderly population. Bone impaction grafting seems not appropriate for pelvic discontinuity and prone to failure in patients with Paprosky type-3B defects. In those cases, a custom-made triflange implant or a cup-cage reconstruction might be the best alternative, but few reports of sufficient quality are available yet.

Level Of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
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http://dx.doi.org/10.2106/JBJS.RVW.15.00119DOI Listing
November 2016

Determination of the Oswestry Disability Index score equivalent to a "satisfactory symptom state" in patients undergoing surgery for degenerative disorders of the lumbar spine-a Spine Tango registry-based study.

Spine J 2016 10 22;16(10):1221-1230. Epub 2016 Jun 22.

Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science NDORMS, Nuffield Orthopaedic Centre, University of Oxford, Windmill Rd, Oxford OX3 7HE, United Kingdom.

Background Context: The achievement of a given change score on a valid outcome instrument is commonly used to indicate whether a clinically relevant change has occurred after spine surgery. However, the achievement of such a change score can be dependent on baseline values and does not necessarily indicate whether the patient is satisfied with the current state. The achievement of an absolute score equivalent to a patient acceptable symptom state (PASS) may be a more stringent measure to indicate treatment success.

Purpose: This study aimed to estimate the score on the Oswestry Disability Index (ODI, version 2.1a; 0-100) corresponding to a PASS in patients who had undergone surgery for degenerative disorders of the lumbar spine.

Study Design/setting: This is a cross-sectional study of diagnostic accuracy using follow-up data from an international spine surgery registry.

Patient Sample: The sample includes 1,288 patients with degenerative lumbar spine disorders who had undergone elective spine surgery, registered in the EUROSPINE Spine Tango Spine Surgery Registry.

Outcome Measures: The main outcome measure was the ODI (version 2.1a).

Methods: Surgical data and data from the ODI and Core Outcome Measures Index (COMI) were included to determine the ODI threshold equivalent to PASS at 1 year (±1.5 months; n=780) and 2 years (±2 months; n=508) postoperatively. The symptom-specific well-being item of the COMI was used as the external criterion in the receiver operating characteristic (ROC) analysis to determine the ODI threshold equivalent to PASS. Separate sensitivity analyses were performed based on the different definitions of an "acceptable state" and for subgroups of patients. JF is a copyright holder of the ODI.

Results: The ODI threshold for PASS was 22, irrespective of the time of follow-up (area under the curve [AUC]: 0.89 [sensitivity {Se}: 78.3%, specificity {Sp}: 82.1%] and AUC: 0.91 [Se: 80.7%, Sp: 85.6] for the 1- and 2-year follow-ups, respectively). Sensitivity analyses showed that the absolute ODI-22 threshold for the two follow-up time-points were robust. A stricter definition of PASS resulted in lower ODI thresholds, varying from 16 (AUC=0.89; Se: 80.2%, Sp: 82.0%) to 18 (AUC=0.90; Se: 82.4%, Sp: 80.4%) depending on the time of follow-up.

Conclusions: An ODI score ≤22 indicates the achievement of an acceptable symptom state and can hence be used as a criterion of treatment success alongside the commonly used change score measures. At the individual level, the threshold could be used to indicate whether or not a patient with a lumbar spine disorder is a "responder" after elective surgery.
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http://dx.doi.org/10.1016/j.spinee.2016.06.010DOI Listing
October 2016

De novo degenerative lumbar scoliosis: a systematic review of prognostic factors for curve progression.

Eur Spine J 2016 08 24;25(8):2347-58. Epub 2016 May 24.

Department of Orthopaedic Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.

Purpose: To identify prognostic factors for curve progression in de novo degenerative lumbar scoliosis (DNDLS) by performing a systematic review of the literature.

Methods: Studies were selected for inclusion following a systematic search in the bibliographic databases PubMed and EMBASE prior to September 2015 and hand searches of the reference lists of retrieved articles. Two authors independently assessed methodological quality. Data were extracted and presented according to a best evidence synthesis.

Results: The literature search generated a total of 2696 references. After removing duplicates and articles that did not meet inclusion criteria, 12 studies were included. Due to the lack of statistical analyses, pooling of data was not possible. Strong evidence indicates that increasing intervertebral disk degeneration, lateral vertebral translation ≥6 mm, and an intercrest line through L5 (rather than L4) are associated with DNDLS curve progression. Moderate evidence suggests that apical vertebral rotation Grade II or III is associated with curve progression. For the majority of other prognostic factors, we found limited, conflicting, or inconclusive evidence. Osteoporosis, a coronal Cobb angle <30°, lumbar lordosis, lateral osteophytes difference of ≥5 mm, and degenerative spondylolisthesis have not been shown to be risk factors. Clinical risk factors for progression were not identified.

Conclusions: This review shows strong evidence that increased intervertebral disk degeneration, an intercrest line through L5, and apical lateral vertebral translation ≥6 mm are associated with DNDLS curve progression. Moderate evidence was found for apical vertebral rotation (Grade II/III) as a risk factor for curve progression. These results, however, may not be directly applicable to the individual patient.
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http://dx.doi.org/10.1007/s00586-016-4619-9DOI Listing
August 2016

Treatment of prosthetic joint infections due to Propionibacterium. Similar results in 60 patients treated with and without rifampicin.

Acta Orthop 2016 Feb 28;87(1):60-6. Epub 2015 Sep 28.

a Department of Orthopaedic Surgery, Prosthetic Joint Infection Unit , Sint Maartenskliniek ;

Background And Purpose: Currently, Propionibacterium is frequently recognized as a causative microorganism of prosthetic joint infection (PJI). We assessed treatment success at 1- and 2-year follow-up after treatment of Propionibacterium-associated PJI of the shoulder, hip, and knee. Furthermore, we attempted to determine whether postoperative treatment with rifampicin is favorable.

Patients And Methods: We conducted a retrospective cohort study in which we included patients with a primary or revision joint arthroplasty of the shoulder, hip, or knee who were diagnosed with a Propionibacterium-associated PJI between November 2008 and February 2013 and who had been followed up for at least 1 year.

Results: We identified 60 patients with a Propionibacterium-associated PJI with a median duration of 21 (0.1-49) months until the occurrence of treatment failure. 39 patients received rifampicin combination therapy, with a success rate of 93% (95% CI: 83-97) after 1 year and 86% (CI: 71-93) after 2 years. The success rate was similar in patients who were treated with rifampicin and those who were not.

Interpretation: Propionibacterium-associated PJI treated with surgery in combination with long-term antibiotic administration had a successful outcome at 1- and 2-year follow-up irrespective of whether the patient was treated with rifampicin. Prospective studies are needed to determine whether the use of rifampicin is beneficial in the treatment of Propionibacterium-associated PJI.
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http://dx.doi.org/10.3109/17453674.2015.1094613DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4940594PMC
February 2016

The impact of trunk impairment on performance of wheelchair activities with a focus on wheelchair court sports: a systematic review.

Sports Med Open 2015 7;1(1):22. Epub 2015 May 7.

Sint Maartenskliniek, Research, Nijmegen, The Netherlands.

Background: Trunk impairment seems to impact significantly on performance in wheelchair court sports, but evidence to support this impression has never been systematically assessed. The objective of this study is to systematically review, describe and synthesise the literature investigating the impact of trunk impairment on wheelchair activities in court sports.

Methods: This systematic review was performed according to the consensus statement for the meta-analysis of observational studies in epidemiology (MOOSE). The search strategy for original articles comprised Medline (1950- November 2014), Cinahl (1981-November 2014), and Embase (1980- November 2014), using the search terms: trunk, trunk muscles, postural balance, posture and wheelchair. Eligibility criteria for further review were 1) participants included experienced wheelchair users, 2) comparisons were made between a) participants with different levels of trunk impairment or b) between able bodied participants and participants with trunk impairment, or c) between participants with trunk impairment with and without compensatory equipment, and 3) outcome measures were quantitative data on wheelchair activities. For methodological quality assessment, the STROBE (Strengthening the reporting of observational studies in epidemiology) checklist was used.

Results: After assessment of 358 potentially relevant studies for the eligibility criteria, 25 studies were appropriate for methodological assessment. Twelve articles fulfilled the predetermined minimum of 15 reported items on the 22-item STROBE checklist. These studies were limited to observational studies with small populations. All but one study were restricted to patients with spinal cord injury (SCI).

Conclusions: Limited evidence was found about the impact of trunk impairment on wheelchair activities. Reach to the front and multidirectional reach was further in able bodied persons than in persons with SCI. In a perturbation that equals deceleration in wheelchair court sports, able bodied persons maintain balance, whereas persons with SCI lose balance. No evidence was found to support a difference in acceleration between persons with partial trunk muscle strength and persons with full trunk muscle strength. For future research, there is a need for a test that includes all types of trunk impairment and identification of activities that determine performance in wheelchair court sports. Furthermore, populations of athletes with all trunk impairment types should be included.
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http://dx.doi.org/10.1186/s40798-015-0013-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5005656PMC
May 2015

Evidence and practice in spine registries.

Acta Orthop 2015 ;86(5):534-44

h 8 Ryhov Hospital Neuro-Orthopedic Department , Futurum Academy, Jönköping , Sweden.

Background And Purpose: We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the "quality of spine care" from spine registries.

Methods: To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries.

Results: 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented.

Interpretation: We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders.
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http://dx.doi.org/10.3109/17453674.2015.1043174DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4564774PMC
December 2015

A proposed set of metrics for standardized outcome reporting in the management of low back pain.

Acta Orthop 2015 ;86(5):523-33

z 26 Department of Orthopaedic Surgery, Ryhov Hospital , Jönköping, Sweden.

Background And Purpose: Outcome measurement has been shown to improve performance in several fields of healthcare. This understanding has driven a growing interest in value-based healthcare, where value is defined as outcomes achieved per money spent. While low back pain (LBP) constitutes an enormous burden of disease, no universal set of metrics has yet been accepted to measure and compare outcomes. Here, we aim to define such a set.

Patients And Methods: An international group of 22 specialists in several disciplines of spine care was assembled to review literature and select LBP outcome metrics through a 6-round modified Delphi process. The scope of the outcome set was degenerative lumbar conditions.

Results: Patient-reported metrics include numerical pain scales, lumbar-related function using the Oswestry disability index, health-related quality of life using the EQ-5D-3L questionnaire, and questions assessing work status and analgesic use. Specific common and serious complications are included. Recommended follow-up intervals include 6, 12, and 24 months after initiating treatment, with optional follow-up at 3 months and 5 years. Metrics for risk stratification are selected based on pre-existing tools.

Interpretation: The outcome measures recommended here are structured around specific etiologies of LBP, span a patient's entire cycle of care, and allow for risk adjustment. Thus, when implemented, this set can be expected to facilitate meaningful comparisons and ultimately provide a continuous feedback loop, enabling ongoing improvements in quality of care. Much work lies ahead in implementation, revision, and validation of this set, but it is an essential first step toward establishing a community of LBP providers focused on maximizing the value of the care we deliver.
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http://dx.doi.org/10.3109/17453674.2015.1036696DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4564773PMC
December 2015

Mobile bearing vs fixed bearing prostheses for posterior cruciate retaining total knee arthroplasty for postoperative functional status in patients with osteoarthritis and rheumatoid arthritis.

Cochrane Database Syst Rev 2015 Feb 4(2):CD003130. Epub 2015 Feb 4.

Department of Medical Decision Making, Leiden University Medical Center, Postzone J10-s, room J10-88, P.O. Box 9600, Leiden, Netherlands, 2300 RC.

Background: It is unclear whether there are differences in benefits and harms between mobile and fixed prostheses for total knee arthroplasty (TKA). The previous Cochrane review published in 2004 included two articles. Many more trials have been performed since then; therefore an update is needed.

Objectives: To assess the benefits and harms of mobile bearing compared with fixed bearing cruciate retaining total knee arthroplasty for functional and clinical outcomes in patients with osteoarthritis (OA) or rheumatoid arthritis (RA).

Search Methods: We searched The Cochrane Library, PubMed, EMBASE, CINAHL and Web of Science up to 27 February 2014, and the trial registers ClinicalTrials.gov, Multiregister, Current Controlled Trials and the World Health Organization (WHO) International Clinical Trials Registry Platform for data from unpublished trials, up to 11 February 2014. We also screened the reference lists of selected articles.

Selection Criteria: We selected randomised controlled trials comparing mobile bearing with fixed bearing prostheses in cruciate retaining TKA among patients with osteoarthritis or rheumatoid arthritis, using functional or clinical outcome measures and follow-up of at least six months.

Data Collection And Analysis: We used standard methodological procedures as expected by The Cochrane Collaboration.

Main Results: We found 19 studies with 1641 participants (1616 with OA (98.5%) and 25 with RA (1.5%)) and 2247 knees. Seventeen new studies were included in this update.Quality of the evidence ranged from moderate (knee pain) to low (other outcomes). Most studies had unclear risk of bias for allocation concealment, blinding of participants and personnel, blinding of outcome assessment and selective reporting, and high risk of bias for incomplete outcome data and other bias. Knee painWe calculated the standardised mean difference (SMD) for pain, using the Knee Society Score (KSS) and visual analogue scale (VAS) in 11 studies (58%) and 1531 knees (68%). No statistically significant differences between groups were reported (SMD 0.09, 95% confidence interval (CI) -0.03 to 0.22, P value 0.15). This represents an absolute risk difference of 2.4% points higher (95% CI 0.8% lower to 5.9% higher) on the KSS pain scale and a relative percent change of 0.22% (95% CI 0.07% lower to 0.53% higher). The results were homogeneous. Clinical and functional scores The KSS clinical score did not differ statistically significantly between groups (14 studies (74%) and 1845 knees (82%)) with a mean difference (MD) of -1.06 points (95% CI -2.87 to 0.74, P value 0.25) and heterogeneous results. KSS function was reported in 14 studies (74%) with 1845 knees (82%) as an MD of -0.10 point (95% CI -1.93 to 1.73, P value 0.91) and homogeneous results. In two studies (11%), the KSS total score was favourable for mobile bearing (159 vs 132 for fixed bearing), with MD of -26.52 points (95% CI -45.03 to -8.01, P value 0.005), but with a wide 95% confidence interval indicating uncertainty about the estimate.Other reported scoring systems did not show statistically significant differences: Hospital for Special Surgery (HSS) score (seven studies (37%) in 1021 knees (45%)) with an MD of -1.36 (95% CI -4.18 to 1.46, P value 0.35); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score (two studies (11%), 167 knees (7%)) with an MD of -4.46 (95% CI -16.26 to 7.34, P value 0.46); and Oxford total (five studies (26%), 647 knees (29%) with an MD of -0.25 (95% CI -1.41 to 0.91, P value 0.67). Health-related quality of lifeThree studies (16%) with 498 knees (22%) reported on health-related quality of life, and no statistically significant differences were noted between the mobile bearing and fixed bearing groups. The Short Form (SF)-12 Physical Component Summary had an MD of -1.96 (95% CI -4.55 to 0.63, P value 0.14) and heterogeneous results. Revision surgeryTwenty seven revisions (1.3%) were performed in 17 studies (89%) with 2065 knees (92%). In all, 13 knees were revised in the fixed bearing group and 14 knees in the mobile bearing group. No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.58), and homogeneous results were reported. MortalityIn seven out of 19 studies, 13 participants (37%) died. Two of these participants had undergone bilateral surgery, and for seven participants, it was unclear which prosthesis they had received; therefore they were excluded from the analyses. Thus our analysis included four out of 191 participants (2.1%) who had died: one in the fixed bearing group and three in the mobile bearing group. No statistically significant differences were found. The risk difference was -0.02 (95% CI -0.06 to 0.03, P value 0.49) and results were homogeneous. Reoperation ratesThirty reoperations were performed in 17 studies (89%) with 2065 knees (92%): 18 knees in the fixed bearing group (of the 1031 knees) and 12 knees in the mobile group (of the 1034 knees). No statistically significant differences were found. The risk difference was -0.01 (95% CI -0.01 to 0.01, P value 0.99) with homogeneous results. Other serious adverse eventsSixteen studies (84%) reported nine other serious adverse events in 1735 knees (77%): four in the fixed bearing group (of the 862 knees) and five in the mobile bearing group (of the 873 knees). No statistically significant differences were found (risk difference 0.00, 95% CI -0.01 to 0.01, P value 0.88), and results were homogeneous.

Authors' Conclusions: Moderate- to low-quality evidence suggests that mobile bearing prostheses may have similar effects on knee pain, clinical and functional scores, health-related quality of life, revision surgery, mortality, reoperation rate and other serious adverse events compared with fixed bearing prostheses in posterior cruciate retaining TKA. Therefore we cannot draw firm conclusions. Most (98.5%) participants had OA, so the findings primarily reflect results reported in participants with OA. Future studies should report in greater detail outcomes such as those presented in this systematic review, with sufficient follow-up time to allow gathering of high-quality evidence and to inform clinical practice. Large registry-based studies may have added value, but they are subject to treatment-by-indication bias. Therefore, this systematic review of RCTs can be viewed as the best available evidence.
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http://dx.doi.org/10.1002/14651858.CD003130.pub3DOI Listing
February 2015

The Oswestry Disability Index (version 2.1a): validation of a Dutch language version.

Spine (Phila Pa 1976) 2015 Jan;40(2):E83-90

*Departments of Research and †Orthopedics, Sint Maartenskliniek, GM Nijmegen, The Netherlands ‡Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Science, University of Oxford, Nuffield Orthopaedic Centre, Oxford, United Kingdom §Achmea Health Insurance Company, AW Zeist, The Netherlands; and ¶Department of Neurosurgery, Leiden University Medical Center, RC Leiden, The Netherlands.

Study Design: A cross-sectional study on baseline data.

Objective: To translate the Oswestry Disability Index (ODI) version 2.1a into the Dutch language and to validate its use in a cohort of patients with chronic low back pain in secondary spine care.

Summary Of Background Data: Patient-reported outcome measures (PROMs) are commonly accepted to evaluate the outcome of spine interventions. Functional status is an important outcome in spine research. The ODI is a recommended condition-specific patient-reported outcome measure used to evaluate functional status in patients with back pain. As yet, no formal translated Dutch version exists.

Methods: The ODI was translated according to established guidelines. The final version was built into the electronic web-based system in addition with the Roland Morris Disability Questionnaire, the numeric rating scale for pain severity, 36-Item Short Form Health Survey Questionnaire for quality of life, and the hospital anxiety and depression scale. Baseline data were used of 244 patients with chronic low back pain who participated in a combined physical and psychological program. Floor and ceiling effects, internal consistency, and the construct validity were evaluated using quality criteria.

Results: The mean ODI (standard deviation) was 39.6 (12.3); minimum 6, maximum 70. Most of the participants (88%) were moderately to severely disabled. Factor analysis determined a 1-factor structure (36% explained variance) and the homogeneity of ODI items is shown (Cronbach α = 0.79). The construct validity is supported as all (6:6) the a priori hypotheses were confirmed. Moreover, the ODI and Roland Morris Disability Questionnaire, showed a strong significant correlation (r = 0.68, P < 0.001) and an overlap: mean difference of -18 (95% limits of agreement: -44 to 8).

Conclusion: The Dutch ODI version 2.1a is a valid and valuable tool for the measurement of functional status and disability among Dutch patients with chronic low back pain. This translated condition-specific patient-reported outcome measure version is recommended for use in future back pain research and to evaluate outcome of back care in the Netherlands.
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http://dx.doi.org/10.1097/BRS.0000000000000683DOI Listing
January 2015

The Nijmegen decision tool for chronic low back pain. Development of a clinical decision tool for secondary or tertiary spine care specialists.

PLoS One 2014 18;9(8):e104226. Epub 2014 Aug 18.

Sint Maartenskliniek, Department of Orthopedics, Nijmegen, The Netherlands; VU University Medical Center, Department of Orthopedics, Amsterdam, The Netherlands.

Background: In Western Europe, low back pain has the greatest burden of all diseases. When back pain persists, different medical specialists are involved and a lack of consensus exists among these specialists for medical decision-making in Chronic Low Back Pain (CLBP).

Objective: To develop a decision tool for secondary or tertiary spine care specialists to decide which patients with CLBP should be seen by a spine surgeon or by other non-surgical medical specialists.

Methods: A Delphi study was performed to identify indicators predicting the outcome of interventions. In the preparatory stage evidence from international guidelines and literature were summarized. Eligible studies were reviews and longitudinal studies. Inclusion criteria: surgical or non-surgical interventions and persistence of complaints, CLBP-patients aged 18-65 years, reported baseline measures of predictive indicators, and one or more reported outcomes had to assess functional status, quality of life, pain intensity, employment status or a composite score. Subsequently, a three-round Delphi procedure, to reach consensus on candidate indicators, was performed among a multidisciplinary panel of 29 CLBP-professionals (>five years CLBP-experience). The pre-set threshold for general agreement was ≥70%. The final indicator set was used to develop a clinical decision tool.

Results: A draft list with 53 candidate indicators (38 with conclusive evidence and 15 with inconclusive evidence) was included for the Delphi study. Consensus was reached to include 47 indicators. A first version of the decision tool was developed, consisting of a web-based screening questionnaire and a provisional decision algorithm.

Conclusions: This is the first clinical decision tool based on current scientific evidence and formal multidisciplinary consensus that helps referring the patient for consultation to a spine surgeon or a non-surgical spine care specialist. We expect that this tool considerably helps in clinical decision-making spine care, thereby improving efficient use of scarce sources and the outcomes of spinal interventions.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0104226PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4136789PMC
May 2015

Predictive factors for successful clinical outcome 1 year after an intensive combined physical and psychological programme for chronic low back pain.

Eur Spine J 2014 Jan 16;23(1):102-12. Epub 2013 Jun 16.

Sint Maartenskliniek, P.O. Box 9011, 6500 GM, Nijmegen, The Netherlands,

Purpose: The aim of this longitudinal study is to determine the factors which predict a successful 1-year outcome from an intensive combined physical and psychological (CPP) programme in chronic low back pain (CLBP) patients.

Methods: A prospective cohort of 524 selected consecutive CLBP patients was followed. Potential predictive factors included demographic characteristics, disability, pain and cognitive behavioural factors as measured at pre-treatment assessment. The primary outcome measure was the oswestry disability index (ODI). A successful 1-year follow-up outcome was defined as a functional status equivalent to 'normal' and healthy populations (ODI ≤22). The 2-week residential programme fulfills the recommendations in international guidelines. For statistical analysis we divided the database into two equal samples. A random sample was used to develop a prediction model with multivariate logistic regression. The remaining cases were used to validate this model.

Results: The final predictive model suggested being 'in employment' at pre-treatment [OR 3.61 (95 % CI 1.80-7.26)] and an initial 'disability score' [OR 0.94 (95 % CI 0.92-0.97)] as significant predictive factors for a successful 1-year outcome (R (2) = 22 %; 67 % correctly classified). There was no predictive value from measures of psychological distress.

Conclusion: CLBP patients who are in work and mild to moderately disabled at the start of a CPP programme are most likely to benefit from it and to have a successful treatment outcome. In these patients, the disability score falls to values seen in healthy populations. This small set of factors is easily identified, allowing selection for programme entry and triage to alternative treatment regimes.
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http://dx.doi.org/10.1007/s00586-013-2844-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3897840PMC
January 2014

A short, intensive cognitive behavioral pain management program reduces health-care use in patients with chronic low back pain: two-year follow-up results of a prospective cohort.

Eur Spine J 2012 Jul 3;21(7):1257-64. Epub 2011 Dec 3.

Department Research Development and Education, Sint Maartenskliniek, PO Box 9011, 6500 GM Nijmegen, The Netherlands.

Purpose: Cognitive behavioral interventions are recommended as non-invasive treatment options for patients with chronic low back pain (CLBP). However, most treatment effects are small and short-lived. Although a 2-week intensive pain management program for patients with CLBP seems to be effective, the long-term results are not known. The purpose of this study is to evaluate the stability of the 2-year follow-up results and whether this is reflected in the use of health-care services.

Methods: A prospective cohort study was performed. Pre-treatment characteristics of patients and data of outcomes obtained at 1-year follow-up were used. At 2-year follow-up a structured interview was conducted following the principles of a post-marketing survey. Outcomes included daily functioning, quality of life, current intensity of pain, disturbance of pain during daily activities, and indicators of the use of pain medication and health-care services.

Results: Of the 90 eligible patients 85 (94%) participated in the post-marketing survey. The 1-year clinical relevant effects are maintained at 2-year follow-up. Effect sizes for functioning and quality of life were large. More than 65% reached preset minimal clinically important differences. At pre-treatment all patients consulted their general practitioner (GP) and medical specialist (MS). At 2-year follow-up 73% reported having consulted neither a GP nor an MS during the previous year. Most of the patients indicated not to use any pain medication (57%) and the percentage patients using opioids have decreased (14%). Moreover, 81% reported to be at work.

Conclusions: The gained results from selected and motivated patients with longstanding CLBP at 1-year follow-up are stable at 2-year follow-up. Above all, most of the participants are at work and results indicate that the use of both pain medication and health care have decreased substantially.
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http://dx.doi.org/10.1007/s00586-011-2091-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3389101PMC
July 2012

Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management.

Eur Spine J 2010 Sep 27;19(9):1517-26. Epub 2010 May 27.

Department Research Development and Education, Sint Maartenskliniek, PO Box 9011, 6500 GM Nijmegen, The Netherlands.

Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen's d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes.
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Source
http://dx.doi.org/10.1007/s00586-010-1435-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2989287PMC
September 2010