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- Hellum, C., et al.
(författare)
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Surgery in degenerative spondylolisthesis: does fusion improve outcome in subgroups? A secondary analysis from a randomized trial (NORDSTEN trial)
- 2023
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Ingår i: Spine Journal. - 1529-9430. ; 23:11, s. 1613-1622
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND CONTEXT: Patients with spinal stenosis and degenerative spondylolisthesis are treated surgically with decompression alone or decompression with fusion. However, there is debate regarding which subgroups of patients may benefit from additional fusion. PURPOSE: To investigate possible treatment effect modifiers and prognostic variables among patients operated for spinal stenosis and degenerative spondylolisthesis. DESIGN: A secondary exploratory study using data from the Norwegian Degenerative Spondylo-listhesis and Spinal Stenosis (NORDSTEN-DS) trial. Patients were randomized to decompression alone or decompression with instrumented fusion. PATIENT SAMPLE: The sample in this study consists of 267 patients from a randomized multi-center trial involving 16 hospitals in Norway. Patients were enrolled from February 12, 2014, to December 18, 2017. The study did not include patients with degenerative scoliosis, severe forami-nal stenosis, multilevel spondylolisthesis, or previous surgery. OUTCOME MEASURES: The primary outcome was an improvement of >= 30% on the Oswestry Disability Index score (ODI) from baseline to 2-year follow-up. METHODS: When investigating possible variables that could modify the treatment effect, we ana-lyzed the treatment arms separately. When testing for prognostic factors we analyzed the whole cohort (both treatment groups). We used univariate and multiple regression analyses. The selection of variables was done a priori, according to the published trial protocol. RESULTS: Of the 267 patients included in the trial (183 female [67%]; mean [SD] age, 66 [7.6] years), complete baseline data for the variables required for the present analysis were available for 205 of the 267 individuals. We did not find any clinical or radiological variables at baseline that modified the treatment effect. Thus, none of the commonly used criteria for selecting patients for fusion surgery influenced the chosen primary outcome in the two treatment arms. For the whole cohort, less comorbidity (American Society of Anesthesiologists Classification [ASA], OR = 4.35; 95% confidence interval (CI [1.16-16.67]) and more preoperative leg pain (OR = 1.23; CI [1.02 -1.50]) were significantly associated with an improved primary outcome. CONCLUSIONS: In this study on patients with degenerative spondylolisthesis, neither previously defined instability criteria nor other pre-specified baseline variables were associated with better clinical outcome if fusion surgery was performed. None of the analyzed variables can be applied to guide the decision for fusion surgery in patients with degenerative spondylolisthesis. For both treat-ment groups, less comorbidity and more leg pain were associated with improved outcome 2 years after surgery. TRIAL REGISTRATION: NORDSTEN-DS ClinicalTrials.gov, NCT02051374. (c) 2023 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/)
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| 2. |
- Hermansen, E., et al.
(författare)
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Comparison of 3 Different Minimally Invasive Surgical Techniques for Lumbar Spinal Stenosis A Randomized Clinical Trial
- 2022
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Ingår i: Jama Network Open. - : American Medical Association (AMA). - 2574-3805. ; 5:3
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE Operations for lumbar spinal stenosis is the most often performed surgical procedure in the adult lumbar spine. This study reports the clinical outcome of the 3 most commonly used minimally invasive posterior decompression techniques. OBJECTIVE To compare the effectiveness of 3 minimally invasive posterior decompression techniques for lumbar spinal stenosis. DESIGN, SETTING. AND PARTICIPANTS This randomized clinical trial used a parallel group design and included patients with symptomatic and radiologically verified lumbar spinal stenosis without degenerative spondylolisthesis. Patients were enrolled between February 2014 and October 2018 at the orthopedic and neurosurgical departments of 16 Norwegian public hospitals. Statistical analysis was performed in the period from May to June 2021. INTERVENTIONS Patients were randomized to undergo 1 of the 3 minimally invasive posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy, and spinous process osteotomy. MAIN OUTCOMES AND MEASURES Primary outcome was change in disability measured with Oswestry Disability Index (ODI; range 0-100), presented as mean change from baseline to 2-year follow-up and proportions of patients classified as success (>30% reduction in ODI). Secondary outcomes were mean change in quality of life, disease-specific symptom severity measured with Zurich Claudication Questionnaire (ZCQ), back pain and leg pain on a 10-point numeric rating score (NRS), patient perceived benefit of the surgical procedure, duration of the surgical procedure, blood loss, perioperative complications, number of reoperations, and length of hospital stay. RESULTS In total, 437 patients were included with a median (IQR) age of 68 (62-73) years and 230 men (53%). Of the included patients, 146 were randomized to unilateral laminotomy with crossover, 142 to bilateral laminotomy, and 149 to spinous process osteotomy. The unilateral laminotomy with crossover group had a mean change of -17.9 ODI points (95% CI, -20.8 to -14.9), the bilateral laminotomy group had a mean change of -19.7 ODI points (95% CI, -22.7 to -16.8), and the spinous process osteotomy group had a mean change of -19.9 ODI points (95% CI, -22.8 to-17.0). There were no significant differences in primary or secondary outcomes amongthe 3 surgical procedures, except a longer duration of the surgical procedure in the bilateral laminotomy group. CONCLUSIONS AND RELEVANCE No differences in clinical outcomes or complication rates were found among the 3 minimally invasive posterior decompression techniques used to treat patients with lumbar spinal stenosis.
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| 4. |
- de Lange, Annet H., et al.
(författare)
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Opportunities and challenges in designing and evaluating complex multilevel, multi-stakeholder occupational health interventions in practice
- 2024
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Ingår i: Work & Stress. - : Taylor & Francis. - 0267-8373 .- 1464-5335.
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Tidskriftsartikel (refereegranskat)abstract
- Extant research suggests the effectiveness of Occupational Health Psychology (OHP) interventions depends on their design in the broader organisational context. While the field recognises that pre- and posttest evaluation do not sufficiently capture the complex dynamics around OHP interventions, complex multi-level OHP interventions are still scarce in the literature. As established intervention implementation frameworks suggest, it remains difficult to address this complexity in practice. The present position paper re-evaluates lessons learned from two complex European OHP intervention projects, by applying the Integrated Process Evaluation Framework (IPEF) and related theories to bridge the gap between the theoretically recognised complexity and practical challenges. The re-evaluations emphasise that programme-multilevel theories rooted in OHP-perspectives contribute to adequately hypothesising around systemic factors and mechanisms relevant to OHP interventions. Concretely, middle range theories that outline how an intervention’s mechanisms work within a specific context to produce certain outcomes are crucial. Additionally, strategically and actively involving key stakeholders at all levels of the system and across the different intervention phases improves the embedding of OHP interventions in organisations. We elaborate on these insights with seven concrete recommendations for complex OHP intervention research.
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