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PURPOSE: To determine whether there was a reduction in fracture incidence amongst children with OI who were treated with both bisphosphonates and orthoses. OBJECTIVE: Was there an additional reduction in fracture incidence amongst children with Osteogenesis Imperfecta (OI) treated with both bisphosphonates and Hip-Knee-Ankle-Foot-Orthosis (HKAFO)? MATERIALS AND METHODS: Of the 129 OI patients treated from 1990 to 2017, retrospective data from 48 patients who participated in the bisphosphonates-orthosis regime were analyzed including the incidence of fractures and modalities of fracture treatment. RESULTS: Bisphosphonates usage was more frequent than bracing and there were more positive changes (smaller or equal number of fractures each year) than negative changes (more fractures each year); negative changes were scarce, explained by non-compliance with the use of bracing. Poisson regression models were significant for positive changes, whereas the interaction between them was borderline significant. The main finding is that the association between bisphosphonates usage and the number of positive changes was stronger among the patients who used braces more frequently and weaker among patients who used bracing less frequently. CONCLUSIONS: Bracing of OI patients has an additive effect on bisphosphonate treatment in fracture prevention which should lead to the reconsideration of a hybrid approach to OI management.
Two key goals of treatment of Osteogenesis Imperfecta (OI) patients include decreasing fracture incidence and improving function and independence as supported by a multi-disciplinary approach that combines medical, orthopaedic and rehabilitation treatments.Although the literature provides evidence that bisphosphonates reduce the frequency of fractures, there have not been reports of its effect when used with orthoses.Orthoses for OI patients have an additive effect on bisphosphonate treatment in fracture prevention.These results contribute to making an informed decision regarding this hybrid approach to OI management.
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Fraturas Ósseas , Osteogênese Imperfeita , Criança , Humanos , Difosfonatos/efeitos adversos , Osteogênese Imperfeita/complicações , Osteogênese Imperfeita/tratamento farmacológico , Incidência , Estudos Retrospectivos , Fraturas Ósseas/epidemiologia , Fraturas Ósseas/etiologia , Fraturas Ósseas/prevenção & controle , Aparelhos OrtopédicosRESUMO
Habitat selection studies facilitate assessing and predicting species distributions and habitat connectivity, but habitat selection can vary temporally and among individuals, which is often ignored. We used GPS telemetry data from 96 Gray wolves (Canis lupus) in the western Great Lakes region of the USA to assess differences in habitat selection while wolves exhibited resident (territorial) or non-resident (dispersing or floating) movements and discuss implications for habitat connectivity. We used a step-selection function (SSF) to assess habitat selection by wolves exhibiting resident or non-resident movements, and modeled circuit connectivity throughout the western Great Lakes region. Wolves selected for natural land cover and against areas with high road densities, with no differences in selection among wolves when resident, dispersing, or floating. Similar habitat selection between resident and non-resident wolves may be due to similarity in environmental conditions, when non-resident movements occur largely within established wolf range rather than near the periphery or beyond the species range. Alternatively, non-resident wolves may travel through occupied territories because higher food availability or lower human disturbance outweighs risks posed by conspecifics. Finally, an absence of differences in habitat selection between resident and non-resident wolf movements may be due to other unknown reasons. We recommend considering context-dependency when evaluating differences in movements and habitat use between resident and non-resident individuals. Our results also provide independent validation of a previous species distribution model and connectivity analysis suggesting most potential wolf habitat in the western Great Lakes region is occupied, with limited connectivity to unoccupied habitat.
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Lobos , Humanos , Animais , Ecossistema , Territorialidade , Movimento , Great Lakes RegionRESUMO
PURPOSE: Neurological damage is the main cause of death or withdrawal of care in comatose survivors of cardiac arrest (CA). Hypoxemia and hyperoxemia following CA were described as potentially harmful, but reports were inconsistent. Current guidelines lack specific oxygen targets after return of spontaneous circulation (ROSC). OBJECTIVES: The current meta-analysis assessed the effects of restrictive compared to high-dose oxygenation strategy in survivors of CA. METHODS: A structured literature search was performed. Randomized controlled trials (RCTs) comparing two competing oxygenation strategies in post-ROSC management after CA were eligible. The primary end point was short-term survival (≤ 90 days). The meta-analysis was prospectively registered in PROSPERO database (CRD42023444513). RESULTS: Eight RCTs enrolling 1941 patients were eligible. Restrictive oxygenation was applied to 964 patients, high-dose regimens were used in 977 participants. Short-term survival rate was 55.7% in restrictive and 56% in high-dose oxygenation group (8 trials, RR 0.99, 95% CI 0.90 to 1.10, P = 0.90, I2 = 18%, no difference). No evidence for a difference was detected in survival to hospital discharge (5 trials, RR 0.98, 95% CI 0.79 to 1.21, P = 0.84, I2 = 32%). Episodes of hypoxemia more frequently occurred in restrictive oxygenation group (4 trials, RR 2.06, 95% CI 1.47 to 2.89, P = 0.004, I2 = 13%). CONCLUSION: Restrictive and high-dose oxygenation strategy following CA did not result in differences in short-term or in-hospital survival. Restrictive oxygenation strategy may increase episodes of hypoxemia, even with restrictive oxygenation targets exceeding intended saturation levels, but the clinical relevance is unknown. There is still a wide gap in the evidence of optimized oxygenation in post-ROSC management and specific targets cannot be concluded from the current evidence.
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Reanimação Cardiopulmonar , Parada Cardíaca Extra-Hospitalar , Adulto , Humanos , Alta do Paciente , Hipóxia/etiologia , Hipóxia/terapia , HospitaisRESUMO
BACKGROUND: Percutaneous coronary intervention (PCI) is standard of care in patients with acute coronary syndrome (ACS) suitable for interventional revascularization. Intracoronary imaging by optical coherence tomography (OCT) expanded treatment approaches adding diagnostic information and contributing to stent optimization. OBJECTIVES: This meta-analysis aimed to assess the effects of OCT-guided vs. angiography-guided PCI in treatment of ACS. METHODS: A structured literature search was performed. All controlled trials evaluating OCT-guided vs. angiography-guided PCI in patients with ACS were eligible. The primary end point was major adverse cardiac events (MACE). RESULTS: Eight studies enrolling 2612 patients with ACS were eligible. 1263 patients underwent OCT-guided and 1,349 patients angiography-guided PCI. OCT guidance was associated with a 30% lower likelihood of MACE (OR 0.70, 95% CI 0.53-0.93, p = 0.01, I2 = 1%). OCT-guided PCI was also associated with significantly decreased cardiac mortality (OR 0.49, 95% CI 0.25-0.96, p = 0.04, I2 = 0%). There was no detectable difference in all-cause mortality (OR 1.08, 95% CI 0.51-2.31, p = 0.83, I2 = 0). Patients in OCT-guided group less frequently required target lesion revascularization (OR 0.26, 95% CI 0.07-0.95, p = 0.04, I2 = 0%). Analysis of myocardial infarction did not result in significant treatment differences. In subgroup or sensitivity analysis the observed advantages of OCT-guided PCI were not replicable. CONCLUSION: The evidence suggests that PCI guidance with OCT in ACS decreases MACE, cardiac death and target lesion revascularization compared to angiography. On individual study level, in subgroup or sensitivity analyses these advantages were not thoroughly replicable.
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PURPOSE OF REVIEW: Interstitial lung disease (ILD) is now recognized as a common complication of anti-neutrophil cytoplasm antibody (ANCA)-associated vasculitides (AAV), especially myeloperoxidase (MPO)-ANCA-positive AAV and microscopic polyangiitis (MPA). This review focuses on current concepts pertaining to the pathogenesis, clinical assessment, and management of AAV-ILD. RECENT FINDINGS: ILD is typically identified before or at the onset of systemic AAV, and usual interstitial pneumonia (UIP) is the most common CT pattern. MPO-ANCA production, neutrophil extracellular traps formation, reactive oxidative species production, complement activation, environmental exposures, and genetic background might play a role in the pathogenesis of AAV-ILD. Recent research has identified promising biomarkers as potential diagnostic and prognostic tools in AAV-ILD. The optimal treatment for AAV-ILD is not well defined but might rely on a combination of immunosuppression and antifibrotics, especially in patients with progressive lung fibrosis. Despite the effectiveness of current therapies for AAV, the outcome of patients with AAV-ILD remains poor. SUMMARY: ANCA screening should be considered in patients with newly diagnosed ILD. Management of AAV-ILD should be overviewed by a collaborative team comprising vasculitis experts and respirologists. VIDEO ABSTRACT: http://links.lww.com/COPM/A33.
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Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos , Doenças Pulmonares Intersticiais , Humanos , Anticorpos Anticitoplasma de Neutrófilos , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/complicações , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/terapia , Doenças Pulmonares Intersticiais/diagnóstico , Doenças Pulmonares Intersticiais/etiologia , Doenças Pulmonares Intersticiais/terapia , Biomarcadores , Citoplasma/patologiaRESUMO
The parallel accumulation-serial fragmentation (PASEF) approach based on trapped ion mobility spectrometry (TIMS) enables mobility-resolved fragmentation and a higher number of fragments in the same time period compared to conventional MS/MS experiments. Furthermore, the ion mobility dimension offers novel approaches for fragmentation. Using parallel reaction monitoring (prm), the ion mobility dimension allows a more accurate selection of precursor windows, while using data-independent aquisition (dia) spectral quality is improved through ion-mobility filtering. Owing to favorable implementation in proteomics, the transferability of these PASEF modes to lipidomics is of great interest, especially as a result of the high complexity of analytes with similar fragments. However, these novel PASEF modes have not yet been thoroughly evaluated for lipidomics applications. Therefore, data-dependent acquisition (dda)-, dia-, and prm-PASEF were compared using hydrophilic interaction liquid chromatography (HILIC) for phospholipid class separation in human plasma samples. Results show that all three PASEF modes are generally suitable for usage in lipidomics. Although dia-PASEF achieves a high sensitivity in generating MS/MS spectra, the fragment-to-precursor assignment for lipids with both, similar retention time as well as ion mobility, was difficult in HILIC-MS/MS. Therefore, dda-PASEF is the method of choice to investigate unknown samples. However, the best data quality was achieved by prm-PASEF, owing to the focus on fragmentation of specified targets. The high selectivity and sensitivity in generating MS/MS spectra of prm-PASEF could be a potential alternative for targeted lipidomics, e.g., in clinical applications.
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Espectrometria de Mobilidade Iônica , Espectrometria de Massas em Tandem , Humanos , Espectrometria de Massas em Tandem/métodos , Lipidômica/métodos , Cromatografia Líquida/métodos , Confiabilidade dos DadosRESUMO
Invertebrate herbivory can shape plant communities when impacting growth and fitness of some plant species more than other species. Previous studies showed that herbivory varies among plant species and that species-specific herbivory is affected by the diversity of the surrounding plant community. However, mechanisms underlying this variation are still poorly understood. In this study, we investigate how plant traits and plant apparency explain differences in herbivory among plant species and we explore the effect of plant community diversity on these species-specific relationships. We found that species differed in the herbivory they experienced. Forbs were three times more damaged by herbivores than grasses. Variability within grasses was caused by differences in leaf dry matter content (LDMC). Furthermore, higher plant diversity increased herbivory on 15 plant species and decreased herbivory on nine species. Variation within forb and grass species in their response to changing plant diversity was best explained by species' physical resistance (LDMC, forbs) and biomass (grasses). Overall, our results show that herbivory and diversity effects on herbivory differ among species, and that, depending on the plant functional group, either species-specific traits or apparency are driving those differences. Thus, herbivores might selectively consume palatable forbs or abundant grasses with contrasting consequences for plant community composition in grasslands dominated by either forbs or grasses.
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Herbivoria , Invertebrados , Animais , Herbivoria/fisiologia , Invertebrados/fisiologia , Plantas , Poaceae , Biomassa , Ecossistema , BiodiversidadeRESUMO
BACKGROUND: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. METHODS: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. RESULTS: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. CONCLUSION: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. LEVEL OF EVIDENCE: Level II.
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Background: Many people with refugee backgrounds suffer from trauma-related complex social and psychological problems, and compliance with standard psychological treatment tends to be low. More culturally adaptable treatment options seem to be needed. Objective: We aimed to investigate whether the music therapy method: 'trauma-focused music and imagery' (tr-MI), characterized by a particular focus on arousal and affect regulation, would be equally effective as the standard psychological talk therapies for ameliorating trauma symptoms in Danish refugees. Methods: A pragmatic, noninferiority, parallel, randomized controlled trial with six-month follow-up was carried out at three clinics for refugees in the public mental health services of the Psychiatry (DK). Seventy-four adults diagnosed with posttraumatic stress disorder (PTSD) were allocated to either music therapy sessions (tr-MI, N = 39) or psychological treatment as usual (TAU, N = 35). Western classical music, new age music, and music from the participants' own national culture were used to generate inner imagery, following a phased treatment protocol. Homework entailed listening to music. The primary outcome was the measurement of trauma symptoms by the Harvard Trauma Questionnaire, section IV (HTQ-IV); secondary measures were somatoform and psychoform dissociation (DSS-20), SDQ-20), attachment (RAAS), and well-being (WHO-5). Treatment effects reflected by primary and secondary measures were estimated using linear mixed models. Results: Tr-MI was noninferior to TAU (mean difference at follow-up HTQ-IV: 0.14, CI (-0.10; 0.38), with a - 0.3 noninferiority margin). A high dropout rate of 40% occurred in the TAU group, compared to 5% in the music therapy group. Secondary measures generated small to medium effect sizes in both groups, with significant medium effect sizes for well-being and psychoform dissociation at follow-up in tr-MI. Conclusions: Tr-MI is an innovative form of psychological treatment in refugee mental health services. Trials comparing music therapy to standardized therapy are needed to substantiate the evidence base for tr-MI therapy.
Antecedentes: Muchas personas con antecedente de condición de refugiadas sufren complejos problemas psicológicos y sociales relacionados con el trauma, y el cumplimiento con el tratamiento psicológico estándar tiende a ser bajo. Parecen ser necesarias opciones de tratamiento más culturalmente adaptadas.Objetivo: Apuntamos a investigar si el método de músico-terapia: 'música e imaginería focalizada en el trauma' (tr-MI), caracterizado por un enfoque particular en el nivel de alerta y regulación emocional, podría ser igualmente efectivo como las terapias psicológicas de conversación para aliviar síntomas de trauma en refugiados daneses.Métodos: Se llevó a cabo un ensayo clínico aleatorizado controlado, pragmático, de no inferioridad, paralelo, con seis meses de seguimiento en tres clínicas para refugiados en servicios públicos de salud mental de Psiquiatría en Dinamarca. Setenta y cuatro adultos diagnosticados con Trastorno de estrés postraumático (TEPT) fueron asignados a sesiones de músico-terapia (tr-MI, N = 39) o al tratamiento psicológico de costumbre (TAU, N = 35). Se utilizó música clásica occidental, música new age, y música de la propia cultura nacional de los participantes, para generar imaginería interior, siguiendo un protocolo de tratamiento por fases. La tarea implicaba escuchar música. El resultado principal fue la medición de síntomas de trauma a través del Cuestionario de Trauma de Harvard, sección IV (HTQ-IV); las mediciones secundarias fueron disociación somatomorfa y psicomorfa (DSS-20, SDQ-20), apego (RAAS), y bienestar (WHO-5). Los efectos del tratamiento reflejados por mediciones primarias y secundarias fueron estimados usando modelos lineales mixtos.Resultados: Tr-MI no fue inferior a TAU (diferencia promedio al seguimiento HTQ-IV: 0.14, IC −0.10; 0.38), con un margen de no-inferioridad de −0.3). Una alta tasa de deserción de un 40% ocurrió en el grupo TAU, comparado con un 5% en el grupo de músico-terapia. Las mediciones secundarias generaron tamaños de efecto pequeños a medianos en ambos grupos, con un tamaño del efecto mediano significativo para bienestar y disociación psicomorfa al seguimiento en tr-MI.Conclusiones: Tr-MI es una forma innovadora de tratamiento psicológico en servicios de salud mental para refugiados. Se necesitan ensayos comparando músico-terapia con terapia estandarizada para probar la base de evidencia para la terapia tr-MI.
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Musicoterapia , Psicoterapia , Refugiados/psicologia , Transtornos de Estresse Pós-Traumáticos/terapia , Inquéritos e Questionários/estatística & dados numéricos , Adulto , Assistência à Saúde Culturalmente Competente , Dinamarca , Feminino , Humanos , Masculino , Serviços de Saúde MentalRESUMO
BACKGROUND: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To assess the safety and effectiveness of SIJF using a 3D-printed TTI. METHODS: Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints. RESULTS: Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence. CONCLUSION: In this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed. LEVEL OF EVIDENCE: Level II.
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Parto Obstétrico , Feminino , Humanos , Recém-Nascido , Gravidez , Estudos Prospectivos , UltrassonografiaRESUMO
The diversity of primary producers strongly affects the structure and diversity of species assemblages at other trophic levels. However, limited knowledge exists of how plant diversity effects at small spatial scales propagate to consumer communities at larger spatial scales. We assessed arthropod community ß and γ-diversity in response to experimentally manipulated plant community richness in two long-term grassland biodiversity experiments (Jena, Germany and Cedar Creek, USA) replicated over two years. We calculated arthropod species turnover among all plot combinations (ß-diversity), and accumulated number of arthropod species occurring on (1) all pairwise plot combinations and (2) 40 randomly selected six-plot combinations (γ-diversity). The components of arthropod diversity were tested against two measures of plant diversity, namely average plant α-diversity ( PSR¯ ) and the average difference in plant α-diversity between plots (ΔPSR). Whereas PSR¯ points to the overall importance of plant α-diversity for arthropod community turnover and diversity on a larger scale, ΔPSR represents the role of habitat heterogeneity. We demonstrate that arthropod γ-diversity is supported by high, homogeneous plant α-diversity, despite lower arthropod ß-diversity among high- compared to low-diversity plant communities. We also show that, in six-plot combinations, average plant α-diversity has a positive influence on arthropod γ-diversity only when homogeneity in plant α-diversity is also high. Varying heterogeneity in six-plot combinations showed that combinations consisting solely of plots with an intermediate level of plant α-diversity support a higher number of arthropod species compared to combinations that contain a mix of high- and low-diversity plots. In fact, equal levels of arthropod diversity were found for six-plot combinations with only intermediate or high plant α-diversity, due to saturating benefits of local and larger-scale plant diversity for higher trophic levels. Our results, alongside those of recent observational studies, strongly suggest that maintaining high α-diversity in plant communities is important for conserving multiple components of arthropod diversity. As arthropods carry out a range of essential ecosystem functions, such as pollination and natural pest-control, our findings provide crucial insight for effective planning of human-dominated landscapes to maximize both ecological and economic benefits in grassland systems.
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Artrópodes , Pradaria , Animais , Biodiversidade , Ecossistema , Alemanha , HumanosRESUMO
The recent advent of endovascular procedures has created the unique opportunity to collect and analyze thrombi removed from cerebral arteries, instigating a novel subfield in stroke research. Insights into thrombus characteristics and composition could play an important role in ongoing efforts to improve acute ischemic stroke therapy. An increasing number of centers are collecting stroke thrombi. This paper aims at providing guiding information on thrombus handling, procedures, and analysis in order to facilitate and standardize this emerging research field.
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Isquemia Encefálica , Procedimentos Endovasculares , Acidente Vascular Cerebral , Trombose , Isquemia Encefálica/complicações , Isquemia Encefálica/cirurgia , Humanos , Acidente Vascular Cerebral/cirurgia , TrombectomiaRESUMO
BACKGROUND: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. OBJECTIVE: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). METHODS: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. RESULTS: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). CONCLUSION: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.
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Until the 19th century, lead white was the most important white pigment used in oil paintings. Lead white is typically composed of two crystalline lead carbonates: hydrocerussite [2PbCO3·Pb(OH)2] and cerussite (PbCO3). Depending on the ratio between hydrocerussite and cerussite, lead white can be classified into different subtypes, each with different optical properties. Current methods to investigate and differentiate between lead white subtypes involve invasive sampling on a microscopic scale, introducing problems of paint damage and representativeness. In this study, a 17th century painting Girl with a Pearl Earring (by Johannes Vermeer, c. 1665, collection of the Mauritshuis, NL) was analyzed with a recently developed mobile and noninvasive macroscopic x-ray powder diffraction (MA-XRPD) scanner within the project Girl in the Spotlight. Four different subtypes of lead white were identified using XRPD imaging at the macroscopic and microscopic scale, implying that Vermeer was highly discriminatory in his use of lead white.
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South Africa (SA) is in the process of amending its patent laws. Since its 2011 inception, Fix the Patent Laws, a coalition of 40 patient groups, has advocated for reform of SA's patent laws to improve affordability of medicines in the country. Building on two draft policies (2013, 2017) and a consultative framework (2016) for reform of SA's patent laws, Cabinet approved phase 1 of the Intellectual Property Policy of the Republic of South Africa on 23 May 2018. Fix the Patent Laws welcomed the policy, but highlighted concerns regarding the absence of important technical details, as well as the urgent need for government to develop bills, regulations and guidelines to provide technical detail and to codify and implement patent law reform in the country. In this article, we explore how reforms proposed in SA's new intellectual property policy could improve access to medicine through four medicine case studies.
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Custos de Medicamentos , Acessibilidade aos Serviços de Saúde , Patentes como Assunto/legislação & jurisprudência , Preparações Farmacêuticas/economia , Antineoplásicos/economia , Antivirais/economia , Custos e Análise de Custo , Indústria Farmacêutica , Cloridrato de Erlotinib/economia , Guanina/análogos & derivados , Guanina/economia , Humanos , Fatores Imunológicos/economia , Lenalidomida/economia , Sorafenibe/economia , África do SulRESUMO
Background: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain. Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction. Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899). Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved. Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use. Level of evidence: Level II.
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BACKGROUND: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients' willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored. MATERIALS: An online survey. METHODS: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients' barriers to participation. RESULTS: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery. CONCLUSIONS: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.