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AIMS: For patients with cartilage defects of the knee, a new biocompatible and in situ cross-linkable albumin-hyaluronan-based hydrogel has been developed for matrix-associated autologous chondrocyte implantation (M-ACI) - NOVOCART Inject plus (Ninject; TETEC AG, Reutlingen, Germany). We aimed to estimate the potential cost-effectiveness of NInject, that is not available on the market, yet compared to spheroids of human autologous matrix-associated chondrocytes (Spherox; CO.DON GmbH, Leipzig, Germany) and microfracture. MATERIALS AND METHODS: An early Markov model was developed to estimate the cost-effectiveness in the United Kingdom (UK) from the payer perspective. Transition probabilities, response rates, utility values and costs were derived from literature. Since NInject has not yet been launched and no prices are available, its costs were assumed equal to those of Spherox. Cycle length was set at one year and the time horizon chosen was notional patients' remaining lifetime. Model robustness was evaluated with deterministic and probabilistic sensitivity analyses (DSA; PSA) and value of information analysis (VOIA). The Markov model was built using TreeAge Pro Healthcare. RESULTS: NInject was cost-effective compared to microfracture (ICER: £5,147) while Spherox was extendedly dominated. In sensitivity analyses, the ICER exceeded conventional WTP threshold of £20,000 only when the utility value after successful first treatment with NInject was decreased by 20% (ICER: £69,620). PSA corroborated the cost-effectiveness findings of NInject, compared to both alternatives, with probabilities of 60% of NInject undercutting the aforementioned WTP threshold and being the most cost-effective alternative. The VOIA revealed that obtaining additional evidence on the new technology will likely not be cost-effective for the UK National Health Service. LIMITATIONS AND CONCLUSION: This early Markov model showed that NInject is cost-effective for the treatment of articular cartilage defects in the knee, compared to Spherox and microfracture. However, as the final price of NInject has yet to be determined, the cost-effectiveness analysis performed in this study is provisional, assuming equal prices for NInject and Spherox.
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Cartílago Articular , Fracturas por Estrés , Masculino , Humanos , Análisis Costo-Beneficio , Medicina Estatal , Antígeno Prostático Específico , CondrocitosRESUMEN
OBJECTIVES: This systematic review and meta-analysis focuses on breast cancer screening performance outcomes stratified into breast density, age, and reading procedure using 'digital breast tomosynthesis (DBT) with synthesised two-dimensional mammography (s2D)' compared to 'digital mammography (DM) alone'. METHODS: Studies comparing 'DBT with s2D' and 'DM' were searched in PubMed and Cochrane library. Pooled risk ratios (RR) using fixed or random effects models (F-/REM) for cancer detection rates (CDR), recall rates, interval cancer rates (ICR), biopsy rates, and positive predictive values (PPV) 1-3 were calculated. Outcomes were stratified into breast density (non-dense and dense), age (<60, ≥60), and reading procedure (double-/non-double reading). Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. RESULTS: We identified 13 studies. Using DBT plus s2D compared to DM alone resulted in a higher increase in CDR for dense ([number of studies included, FEM RR, 95% confidence interval (CI)]; n = 3, 1.60, 1.16-2.22) versus non-dense breasts (n = 3, 1.32, 1.08-1.61). Recall rates were lower in dense (n = 2, 0.84, 0.75-0.94), but much lower for non-dense breasts (n = 2, 0.65, 0.59-0.72). Age stratification resulted in small differences in CDR (<60: n = 2, 1.64, 1.18-2.29 / ≥60: n = 2, 1.56, 1.19-2.05). After screening with DBT plus s2D compared to DM alone the risk of being recalled was less in non-double (n = 3, 0.57, 0.54-0.60) than in double reading (n = 5, 0.95, 0.81-1.11) and the risk of cancer detection was higher in double reading (n = 6, 1.53, 1.40-1.67) than in non-double reading (n = 4, 1.17, 1.02-1.33). CONCLUSION: Since only few studies are available for meta-analyses statistical significance strongly depends on single study results. Taking this into account, the most important results concern the increase of CDR in women with dense breasts, the increased CDR in double reading, and the lower recall rates particularly with non-double reading.
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Neoplasias de la Mama , Mamografía , Densidad de la Mama , Neoplasias de la Mama/diagnóstico por imagen , Neoplasias de la Mama/epidemiología , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Mamografía/métodos , Tamizaje Masivo/métodosRESUMEN
STUDY DESIGN: Prospective pre-post study. OBJECTIVES: International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) represents the most frequently used assessment to determine the level and severity of a spinal cord injury (SCI). The guidelines for ISNCSCI are complex and challenging. Knowledge of its correct execution needs to be imparted precisely. The aim of this study was to investigate whether hands-on instructional courses can increase the knowledge of the ISNCSCI examination guidelines. SETTING: European Multicenter Study about SCI. METHODS: Before and after the instructional courses, participants were asked to complete questionnaires. The set of questions covered the most important aspects of the examination guidelines. Attendees were asked to self-rate their occupation and experience in ISNCSCI. RESULTS: The comparison of pretest and posttest results of 164 attendees from 2014 to 2018 revealed an improvement of knowledge reflected by an increase of correct answers from 66 ± 17% before to 89 ± 11% after the course (p < 0.01). The improvement was not associated with occupation (p > 0.1). However, the correctness of pretest results differed concerning both the period of experience with ISNCSCI (p < 0.05) and the course language (p < 0.01), while the frequency of execution resulted in differences in the posttest (p = 0.01). CONCLUSIONS: Instructional courses substantially improve knowledge of the ISNCSCI examination guidelines. Differences in knowledge present before the course leveled off after the course. Comprehensive theoretical training is strongly recommended to ensure reliability and validity of ISNCSCI examinations in clinical routine and research. Albeit being practiced in the instructional courses, the benefit of hands-on training still needs to be systematically evaluated in future studies.
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Traumatismos de la Médula Espinal , Humanos , Examen Neurológico , Estudios Prospectivos , Reproducibilidad de los Resultados , Traumatismos de la Médula Espinal/complicaciones , Traumatismos de la Médula Espinal/diagnóstico , Encuestas y CuestionariosRESUMEN
OBJECTIVES: Digital breast tomosynthesis (DBT) plus digital mammography (DM) in screening is problematic due to increased radiation by the double exposure. Synthesised two-dimensional mammography (s2D) calculated from DBT datasets at no additional dose appears a sensible alternative compared to adding DM. This systematic review and meta-analysis focuses on screening performance outcomes in women screened with DBT plus s2D compared to DM alone. METHODS: PubMed was searched from January 1, 2010, to September 2, 2020. Studies comparing DBT plus s2D to DM alone in breast cancer screening were included. Pooled risk ratios (RR) were estimated for cancer detection rates (CDR), recall rates, interval cancer rates (ICR), biopsy rates, and positive predictive values for recalls (PPV-1), for biopsies recommended (PPV-2), and for biopsies performed (PPV-3). Sensitivity analyses were performed using the leave-one-out approach. Risk of bias (RoB) was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS)-2 tool. RESULTS: Twelve papers covering 414,281 women were included from 766 records identified. CDR is increased ([RR, 95% CI] 1.35, 1.20-1.52), recall rates are decreased (0.79, 0.64-0.98), and PPV-1 is increased (1.69, 1.45-1.96) when using DBT plus s2D compared to DM alone. ICR and biopsy rates did not differ, but PPV-2 respectively PPV-3 increased with DBT plus s2D (1.57, 1.08-2.28 respectively 1.36, 1.17-1.58). Overall RoB of studies was assessed to be low. CONCLUSION: Results show improved diagnostic outcomes with DBT plus s2D compared to DM alone and underline the value of DBT in combination with s2D in breast cancer screening. KEY POINTS: ⢠DBT plus s2D is associated with higher CDR, lower recall rates, and a higher PPV-1 compared to DM alone in breast cancer screening. ⢠No differences in biopsy rates were found between screening modalities, but PPV-2 and PPV-3 were higher in women screened with DBT plus s2D compared to DM alone. ⢠We identified inconsistent results of ICR in two studies comparing DBT plus s2D to DM alone-resulting in no differences when pooling ICR in meta-analysis.
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Neoplasias de la Mama , Detección Precoz del Cáncer , Neoplasias de la Mama/patología , Detección Precoz del Cáncer/métodos , Femenino , Humanos , Mamografía/métodos , Tamizaje Masivo/métodos , Valor Predictivo de las PruebasRESUMEN
AIM OF THE STUDY: The aim of this study was to assess risk factors for prescription of potentially inappropriate medication (PIM) to nursing home residents using the PRISCUS list in 2017. METHODS: Using claims data (AOK) we analysed insured nursing home residents aged 65 or older in 2017. The PRISCUS list was used to identify PIMs. A multivariate logistic regression analysis was performed to analyse risk factors. RESULTS: The study population in 2017 included 259 328 nursing home residents, out of them 25.5% received at least one potentially inappropriate medication (women: 25.6%/men: 24.9%). Female and younger aged nursing home residents had a higher risk for at least one PRISCUS prescription. Polypharmacy, an increasing number of attending physicians, and hospital stays were additional risk factors for a PRISCUS prescription. Furthermore, regional (Bundesland) variations contributed to differences in PRISCUS prescriptions. CONCLUSION: The frequent PIM prescriptions in nursing home residents are a relevant topic regarding drug therapy safety. Regional differences, which cannot be explained by nursing home resident characteristics, show options for modifications and the need for further research.