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1.
Eur Heart J ; 2020 Feb 04.
Artigo em Inglês | MEDLINE | ID: mdl-32016367

RESUMO

The availability of large datasets from multiple sources [e.g. registries, biobanks, electronic health records (EHRs), claims or billing databases, implantable devices, wearable sensors, and mobile apps], coupled with advances in computing and analytic technologies, have provided new opportunities for conducting innovative health research. Equally, improved digital access to health information has facilitated the conduct of efficient randomized controlled trials (RCTs) upon which clinical management decisions can be based, for instance, by permitting the identification of eligible patients for recruitment and/or linkage for follow-up via their EHRs. Given these advances in cardiovascular data science and the complexities they behold, it is important that health professionals have clarity on the appropriate use and interpretation of observational, so-called 'real-world', and randomized data in cardiovascular medicine. The Cardiovascular Roundtable of the European Society of Cardiology (ESC) held a workshop to explore the future of RCTs and the current and emerging opportunities for gathering and exploiting complex observational datasets in cardiovascular research. The aim of this article is to provide a perspective on the appropriate use of randomized and observational data and to outline the ESC plans for supporting the collection and availability of clinical data to monitor and improve the quality of care of patients with cardiovascular disease in Europe and provide an infrastructure for undertaking pragmatic RCTs. Moreover, the ESC continues to campaign for greater engagement amongst regulators, industry, patients, and health professionals in the development and application of a more efficient regulatory framework that is able to take maximal advantage of new opportunities for improving the design and efficiency of observational studies and RCT in patients with cardiovascular disease.

2.
J Biomed Mater Res B Appl Biomater ; 108(1): 225-233, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30977963

RESUMO

Polyethylene wear is one of the major factors influencing the survivorship of joint replacements. Depending on the number, size and morphology of the polyethylene particles, biological responses of the periprosthetic soft tissue in terms of inflammatory processes can occur, leading to loosening of the implant. Various parameters are used to analyze wear particles, which are usually determined by examining scanning electron microscopy (SEM) images with a particle analysis program. In this study, three different software solutions for particle analysis (self-developed Particleanalyzer_HD, Leica QWin and ImageJ) were compared regarding particle number, size and morphology. These solutions were also compared to the American Society for Testing and Materials (ASTM) F1877-16 specifications regarding particle morphology. SEM image analysis revealed no differences for the equivalent circle diameter (p = 0.969). However, a significant difference was found for the aspect ratio between the Particleanalyzer_HD and the other two software solutions (p < 0.001) and between Leica QWin and the other two software solutions regarding the roundness (p < 0.001). Only the Particleanalyzer_HD showed an excellent agreement with the ASTM standard for both morphology parameters (intraclass correlation = 1.000). Only the Particleanalyzer_HD calculated the two morphology parameters according to the ASTM standard. A comparison of the particle morphology between different studies is barely possible, as different algorithms for particle analysis are used. It is strongly recommended that the calculation according to the ASTM standard is used to improve future comparability of findings from wear analysis studies. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:225-233, 2020.

3.
J Mech Behav Biomed Mater ; 101: 103434, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31542569

RESUMO

BACKGROUND: For prosthetic knee joints of the hinged type, typically polyethylene (PE) flexion bushings are used between axis and femoral component to prevent metallic wear. Nevertheless, PE-wear can lead to periprosthetic osteolysis followed by aseptic loosening of the implant. Based on high creep and wear resistance carbon-fibre-reinforced polyether ether ketones (CFR-PEEKs) could provide an alternative material to ultra-high-molecular-weight polyethylene (UHMWPE) for this bearing type. METHODS: Flexion bushings of four different materials were investigated (CFR-PEEK pitch fibres, CFR-PEEK PAN fibres, virgin PEEK without carbon fibres and UHMWPE) using a bushing tester. For determination of the polymeric and metallic wear, gravimetric measurements and particle analyses were performed. RESULTS: The polymeric wear rates of CFR-PEEK PAN (6.657 ±â€¯0.714 mg/106 cycles) and CFR-PEEK pitch (32.085 ±â€¯2.748 mg/106 cycles) were significantly higher compared to the polymeric wear rates of virgin PEEK (0.764 ±â€¯0.283 mg/106 cycles) or UHMWPE (-0.015 ±â€¯0.011 mg/106 cycles) (p < .001). In addition, the metallic wear rates were significantly higher when using bushings made of CFR-PEEK PAN (3.373 ±â€¯0.214 mg/106 cycles) and CFR-PEEK pitch (3.604 ±â€¯0.355 mg/106 cycles), than when using bushings made of virgin PEEK (0.177 ±â€¯0.049 mg/106 cycles) or UHMWPE (0.031 ±â€¯0.011 mg/106 cycles) (p < .001). The mean particle size of the two CFR-PEEK groups was significantly smaller compared to the virgin PEEK and UHMWPE group (p < .001). CONCLUSION: According to these results, the clinical use of CFR-PEEK in combination with CoCr could lead to higher wear rates and this should be avoided. Virgin PEEK may still be considered as an alternative to UHMWPE to use it for flexion bushings in a hinged knee joint.

4.
Acta Biomater ; 97: 239-246, 2019 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-31374340

RESUMO

In total hip arthroplasty, osteolysis of the acetabulum often occurs at the backside of cups in the area of screw holes, indicating a clinically relevant amount of polyethylene (PE) wear particles in this area. In order to avoid a possible migration of wear particles to the acetabulum-bone, screw hole plugs are provided for some implant systems. The aims of this study were to quantitatively determine backside wear and to investigate the migration behaviour of articulation-related wear particles in a cup system with open and closed screw holes by plugs. Titanium cup systems with backside holes for screw fixations were sinusoidally loaded with 2.7 kN. The articulation area was separated from the backside area of the cup. A defined amount of articulation-generated particles was added to the fluid of the articulation chamber. The fluids in the two chambers were separately filtered after 2 × 106 cycles for a particle analysis. Backside wear with noticeably small (65.6 ±â€¯4.2 nm) and round PE particles was identified. With both open and closed screw holes, a migration of the articulating wear particles from the articulation area behind the cup could be observed. Backside wear was estimated to be below 1% of the articulated wear. Screw hole plugs did not effectively prevent the migration of PE wear particles behind the investigated cups. STATEMENT OF SIGNIFICANCE: Backside wear occurs in a proven cup-system. Furthermore, it was quantitatively observed that articulation-generated wear products could migrate from the articulating area along the cup/liner-interface through the screw holes behind the cup. An almost unimpeded particle migration to the acetabulum-bone, in conjunction with very small backside wear particles, could produce a clinically relevant amount of PE with respect to pelvic lysis. These findings highlight the importance of management to avoid particle migration in artificial hip cups. Therefore, primarily the use of screw hole plugs, as far as available for the respective cup-system, is recommended. The aim of avoiding particle migration by plugs, but also by using a sophisticated anchoring mechanism between cup and PE liner should continue in future.

5.
Expert Rev Med Devices ; 16(2): 119-133, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30608000

RESUMO

INTRODUCTION: To improve the total knee arthroplasty (TKA) prosthesis design, it is essential to study the kinematics of the tibiofemoral joint. Many studies have been conducted in this area; however, conflicting results and incomparable testing methods make it difficult to draw definitive conclusions or compare research from studies. The goal of this article is to introduce what is known about both healthy and prosthetic tibiofemoral joint kinematics. AREAS COVERED: Healthy tibiofemoral joint kinematics are reviewed in vivo by different activities, and the kinematics of existing knee prosthetic design features are considered separately. These features include but are not limited to cruciate retaining, posterior cruciate substituting, mobile-bearing, and high flexion. EXPERT COMMENTARY: The type of activity that is being performed has a great influence on the kinematics of healthy knees, and the influences of different TKA prosthetic design features on the kinematics are complex and varied. Moreover, the TKA postoperative functional performance is influenced by many factors, and prosthetic design is among them, but not the only one that defines the performance.


Assuntos
Artroplastia do Joelho , Fêmur/fisiologia , Fêmur/cirurgia , Prótese do Joelho , Tíbia/fisiologia , Tíbia/cirurgia , Fenômenos Biomecânicos , Humanos , Atividade Motora , Desenho de Prótese
6.
Acta Biomater ; 83: 467-476, 2019 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-30408561

RESUMO

INTRODUCTION: Besides head-insert articulation in hip joint replacements, micro-motions between the backside of assembled polyethylene acetabular liners and the metal cup may cause additional wear. Pelvic osteolysis frequently occurs in the region of screw holes, and cup loosening hints to clinically relevant amounts of polyethylene backside wear. It has yet to be confirmed whether backside wear particles differ in size and morphology compared to articulating wear. Previous methods have been limited to subjective assessment of backside surface damages without consideration of wear debris. The aim of this study was to develop and validate a method for quantitative in vitro measurements of polyethylene backside wear in artificial hip cups and to characterize these wear particles for the first time. METHODS: Titanium cup-systems (Plasmafit®Plus7, Aesculap, UHMWPE liner) were sinusoidally loaded (2.5 kN) and a torque of 5 Nm was simultaneously applied. The front and rear side of the cup were separated to isolate backside wear. After 2 × 106 cycles the surrounding fluid was filtered and a particle analysis was performed. RESULTS: Backside wear had a particles size of 64.1 ±â€¯1.9 nm and was verified as round and oval particles with partly rough outlines. An estimated total number of particles of 1.26 × 109 ±â€¯1.67 × 108 per 106 cycles was determined. CONCLUSION: Backside wear was estimated to be several times lower than published values of articulating wear. However, polyethylene backside wear particles represented significantly smaller particles with partly roughened outlines than articulating wear particles and may therefore cause higher biological response in macrophage-mediated bone resorption compared to articulated particles. STATEMENT OF SIGNIFICANCE: Within this study, an analytical method for quantitative measuring polyethylene backside wear of artificial hip cups was successfully developed and validated for the first time. It could be shown that backside wear is still present, even in modern cup-systems. These findings can be further used for investigations of the osteolytic potential of polyethylene particles, for evaluating and improving new implant systems and to evaluate the effectiveness of screw hole plugs to prevent the particle migration to the acetabulum.


Assuntos
Acetábulo , Artroplastia de Quadril , Prótese de Quadril , Polietilenos/química , Desenho de Prótese , Titânio/química , Humanos , Teste de Materiais , Falha de Prótese
7.
Crit Care ; 22(1): 191, 2018 08 15.
Artigo em Inglês | MEDLINE | ID: mdl-30111341

RESUMO

BACKGROUND: The clinical utility of serum procalcitonin levels in guiding antibiotic treatment decisions in patients with sepsis remains unclear. This patient-level meta-analysis based on 11 randomized trials investigates the impact of procalcitonin-guided antibiotic therapy on mortality in intensive care unit (ICU) patients with infection, both overall and stratified according to sepsis definition, severity, and type of infection. METHODS: For this meta-analysis focusing on procalcitonin-guided antibiotic management in critically ill patients with sepsis of any type, in February 2018 we updated the database of a previous individual patient data meta-analysis which was limited to patients with respiratory infections only. We used individual patient data from 11 trials that randomly assigned patients to receive antibiotics based on procalcitonin levels (the "procalcitonin-guided" group) or the current standard of care (the "controls"). The primary endpoint was mortality within 30 days. Secondary endpoints were duration of antibiotic treatment and length of stay. RESULTS: Mortality in the 2252 procalcitonin-guided patients was significantly lower compared with the 2230 control group patients (21.1% vs 23.7%; adjusted odds ratio 0.89, 95% confidence interval (CI) 0.8 to 0.99; p = 0.03). These effects on mortality persisted in a subgroup of patients meeting the sepsis 3 definition and based on the severity of sepsis (assessed on the basis of the Sequential Organ Failure Assessment (SOFA) score, occurrence of septic shock or renal failure, and need for vasopressor or ventilatory support) and on the type of infection (respiratory, urinary tract, abdominal, skin, or central nervous system), with interaction for each analysis being > 0.05. Procalcitonin guidance also facilitated earlier discontinuation of antibiotics, with a reduction in treatment duration (9.3 vs 10.4 days; adjusted coefficient -1.19 days, 95% CI -1.73 to -0.66; p <  0.001). CONCLUSION: Procalcitonin-guided antibiotic treatment in ICU patients with infection and sepsis patients results in improved survival and lower antibiotic treatment duration.


Assuntos
Antibacterianos/administração & dosagem , Avaliação de Resultados da Assistência ao Paciente , Pró-Calcitonina/análise , Sepse/tratamento farmacológico , Antibacterianos/uso terapêutico , Biomarcadores/análise , Biomarcadores/sangue , Humanos , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação , Escores de Disfunção Orgânica , Pró-Calcitonina/sangue , Ensaios Clínicos Controlados Aleatórios como Assunto , Sepse/sangue
8.
Expert Rev Anti Infect Ther ; 16(7): 555-564, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29969320

RESUMO

INTRODUCTION: Although evidence indicates that use of procalcitonin to guide antibiotic decisions for the treatment of acute respiratory infections (ARI) decreases antibiotic consumption and improves clinical outcomes, algorithms used within studies had differences in PCT cut-off points and frequency of testing. We therefore analyzed studies evaluating procalcitonin-guided antibiotic therapy and propose consensus algorithms for different respiratory infection types. Areas covered: We systematically searched randomized-controlled trials (search strategy updated on February 2018) on procalcitonin-guided antibiotic therapy of ARI in adults using a pre-specified Cochrane protocol and analyzed algorithms from 32 trials that included 10,285 patients treated in primary care settings, emergency departments (ED), and intensive care units (ICU). We derived consensus algorithms for use of procalcitonin by the type of ARI including community-acquired pneumonia, bronchitis, chronic obstructive pulmonary disease or asthma exacerbation, sepsis, and post-operative sepsis due to respiratory infection. Consensus algorithm recommendations differ with regard to timing of treatment (i.e. timing of initiation in low-risk patients or discontinuation in high-risk patients) and procalcitonin cut-off points for the recommendation/strong recommendation to discontinue antibiotics (≤ 0.25/≤ 0.1 µg/L in ED and inpatients, ≤ 0.5/≤ 0.25 µg/L in ICU patients, and reduction by ≥ 80% from peak levels in sepsis patients). Expert commentary: Our proposed algorithms may facilitate safe and efficient implementation of procalcitonin-guided antibiotic protocols in diverse healthcare settings. Still, the decision about initiation and cessation of antibiotic treatment remains a clinical decision based on the patient assessment and the severity of illness and use of procalcitonin should not delay empirical treatment in high risk situations.


Assuntos
Antibacterianos/administração & dosagem , Pró-Calcitonina/sangue , Infecções Respiratórias/tratamento farmacológico , Doença Aguda , Adulto , Algoritmos , Infecções Bacterianas/tratamento farmacológico , Infecções Bacterianas/microbiologia , Esquema de Medicação , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções Respiratórias/microbiologia
9.
J Orthop Res ; 36(10): 2745-2753, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29744927

RESUMO

Aseptic loosening is the main reason for revision of total hip arthroplasty, and relative micromotions between cementless acetabular cups and bone play an important role regarding their comparatively high loosening rate. Therefore, the aim of the present study was to analyze the influence of resulting frictional torques on the primary stability of press-fit acetabular cups subjected to two different bearing partners. A cementless press-fit cup was implanted in bone-like foam. Primary stability of the cup was analyzed by determining spatial total, translational, and rotational interface micromotions by means of an eddy current sensor measuring system. Torque transmission into the cup was realized by three synchronous servomotors considering resultant friction torques based on constant friction for ceramic-on-ceramic (CoC: µ = 0.044; max. resultant torque: 1.5 Nm) and for ceramic-on-polyethylene (CoP: µ = 0.063; max. resultant torque: 1.9 Nm) bearing partners. Rotational micromotion of CoC was 8.99 ± 0.85 µm and of CoP 13.39 ± 1.43 µm. Translational micromotion of CoC was 29.93 ± 1.44 µm and of CoP 39.91 ± 2.25 µm. Maximum total relative micromotions were 37.10 ± 1.07 µm for CoC and 51.64 ± 2.18 µm for CoP. Micromotions resulting from CoC were statistically lower than those resulting from CoP (p < 0.05). The described 3D-measuring set-up offers a novel in vitro method of measuring primary stability of acetabular cups. We can therefore conclude, that primary stability of acetabular cup systems can be observed using either the lower friction curve (CoC) or the higher friction curve (CoP). In future studies different cup designs or cup fixation mechanisms may be tested and compared in vitro and assessed prior to implantation. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:2745-2753, 2018.


Assuntos
Prótese de Quadril/estatística & dados numéricos , Fricção , Humanos , Técnicas In Vitro , Torque
10.
J Shoulder Elbow Surg ; 27(9): 1679-1685, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29695317

RESUMO

BACKGROUND: Despite the positive results in total shoulder arthroplasties (TSAs), a higher revision rate is documented compared with total hip and knee replacements. Wear is the possible main cause of TSA failure in the long-term. This study investigated the effect of joint kinematics and the influence of the rotator cuff on the polyethylene wear performance in an anatomic TSA. METHODS: Lifting a load of 2 kg with an abduction/adduction of 0° to 90° was simulated for 2 × 106 cycles as a primary motion using a fully kinematic joint simulator. A combined rotation in anteversion-retroversion of ±5° and ±10° was also simulated. The force in the superior-inferior direction and the axial joint compression were applied under force control based on in vivo data of the shoulder. A soft tissue restraint model was used to simulate an intact and an insufficient rotator cuff. RESULTS: The highest wear rate in the intact rotator cuff group was 58.90 ± 1.20 mg/106 cycles with a combined rotation of ±10°. When an insufficient rotator cuff was simulated, the highest polyethylene wear rate determined was 79.67 ± 4.18 mg/106 cycles. CONCLUSIONS: This study confirms a high dependency of the polyethylene wear behavior and dimension on the joint kinematics in total shoulder replacement. This can be explained by an increasing cross-shear stress on the polyethylene component. The results obtained indicate that additional combined kinematics are an indispensable part of wear tests on anatomic shoulder replacements.


Assuntos
Artroplastia do Ombro/instrumentação , Polietileno , Amplitude de Movimento Articular/fisiologia , Manguito Rotador/fisiologia , Articulação do Ombro/fisiologia , Prótese de Ombro , Humanos , Modelos Biológicos , Falha de Prótese , Rotação , Suporte de Carga/fisiologia
11.
Lancet Infect Dis ; 18(1): 95-107, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29037960

RESUMO

BACKGROUND: In February, 2017, the US Food and Drug Administration approved the blood infection marker procalcitonin for guiding antibiotic therapy in patients with acute respiratory infections. This meta-analysis of patient data from 26 randomised controlled trials was designed to assess safety of procalcitonin-guided treatment in patients with acute respiratory infections from different clinical settings. METHODS: Based on a prespecified Cochrane protocol, we did a systematic literature search on the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase, and pooled individual patient data from trials in which patients with respiratory infections were randomly assigned to receive antibiotics based on procalcitonin concentrations (procalcitonin-guided group) or control. The coprimary endpoints were 30-day mortality and setting-specific treatment failure. Secondary endpoints were antibiotic use, length of stay, and antibiotic side-effects. FINDINGS: We identified 990 records from the literature search, of which 71 articles were assessed for eligibility after exclusion of 919 records. We collected data on 6708 patients from 26 eligible trials in 12 countries. Mortality at 30 days was significantly lower in procalcitonin-guided patients than in control patients (286 [9%] deaths in 3336 procalcitonin-guided patients vs 336 [10%] in 3372 controls; adjusted odds ratio [OR] 0·83 [95% CI 0·70 to 0·99], p=0·037). This mortality benefit was similar across subgroups by setting and type of infection (pinteractions>0·05), although mortality was very low in primary care and in patients with acute bronchitis. Procalcitonin guidance was also associated with a 2·4-day reduction in antibiotic exposure (5·7 vs 8·1 days [95% CI -2·71 to -2·15], p<0·0001) and a reduction in antibiotic-related side-effects (16% vs 22%, adjusted OR 0·68 [95% CI 0·57 to 0·82], p<0·0001). INTERPRETATION: Use of procalcitonin to guide antibiotic treatment in patients with acute respiratory infections reduces antibiotic exposure and side-effects, and improves survival. Widespread implementation of procalcitonin protocols in patients with acute respiratory infections thus has the potential to improve antibiotic management with positive effects on clinical outcomes and on the current threat of increasing antibiotic multiresistance. FUNDING: National Institute for Health Research.


Assuntos
Antibacterianos/administração & dosagem , Infecções Bacterianas/tratamento farmacológico , Infecções Bacterianas/mortalidade , Pró-Calcitonina/sangue , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Antibacterianos/efeitos adversos , Infecções Bacterianas/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções Respiratórias/diagnóstico , Análise de Sobrevida
12.
Cochrane Database Syst Rev ; 10: CD007498, 2017 10 12.
Artigo em Inglês | MEDLINE | ID: mdl-29025194

RESUMO

BACKGROUND: Acute respiratory infections (ARIs) comprise of a large and heterogeneous group of infections including bacterial, viral, and other aetiologies. In recent years, procalcitonin (PCT), a blood marker for bacterial infections, has emerged as a promising tool to improve decisions about antibiotic therapy (PCT-guided antibiotic therapy). Several randomised controlled trials (RCTs) have demonstrated the feasibility of using procalcitonin for starting and stopping antibiotics in different patient populations with ARIs and different settings ranging from primary care settings to emergency departments, hospital wards, and intensive care units. However, the effect of using procalcitonin on clinical outcomes is unclear. This is an update of a Cochrane review and individual participant data meta-analysis first published in 2012 designed to look at the safety of PCT-guided antibiotic stewardship. OBJECTIVES: The aim of this systematic review based on individual participant data was to assess the safety and efficacy of using procalcitonin for starting or stopping antibiotics over a large range of patients with varying severity of ARIs and from different clinical settings. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, MEDLINE, and Embase, in February 2017, to identify suitable trials. We also searched ClinicalTrials.gov to identify ongoing trials in April 2017. SELECTION CRITERIA: We included RCTs of adult participants with ARIs who received an antibiotic treatment either based on a procalcitonin algorithm (PCT-guided antibiotic stewardship algorithm) or usual care. We excluded trials if they focused exclusively on children or used procalcitonin for a purpose other than to guide initiation and duration of antibiotic treatment. DATA COLLECTION AND ANALYSIS: Two teams of review authors independently evaluated the methodology and extracted data from primary studies. The primary endpoints were all-cause mortality and treatment failure at 30 days, for which definitions were harmonised among trials. Secondary endpoints were antibiotic use, antibiotic-related side effects, and length of hospital stay. We calculated odds ratios (ORs) and 95% confidence intervals (CIs) using multivariable hierarchical logistic regression adjusted for age, gender, and clinical diagnosis using a fixed-effect model. The different trials were added as random-effects into the model. We conducted sensitivity analyses stratified by clinical setting and type of ARI. We also performed an aggregate data meta-analysis. MAIN RESULTS: From 32 eligible RCTs including 18 new trials for this 2017 update, we obtained individual participant data from 26 trials including 6708 participants, which we included in the main individual participant data meta-analysis. We did not obtain individual participant data for four trials, and two trials did not include people with confirmed ARIs. According to GRADE, the quality of the evidence was high for the outcomes mortality and antibiotic exposure, and quality was moderate for the outcomes treatment failure and antibiotic-related side effects.Primary endpoints: there were 286 deaths in 3336 procalcitonin-guided participants (8.6%) compared to 336 in 3372 controls (10.0%), resulting in a significantly lower mortality associated with procalcitonin-guided therapy (adjusted OR 0.83, 95% CI 0.70 to 0.99, P = 0.037). We could not estimate mortality in primary care trials because only one death was reported in a control group participant. Treatment failure was not significantly lower in procalcitonin-guided participants (23.0% versus 24.9% in the control group, adjusted OR 0.90, 95% CI 0.80 to 1.01, P = 0.068). Results were similar among subgroups by clinical setting and type of respiratory infection, with no evidence for effect modification (P for interaction > 0.05). Secondary endpoints: procalcitonin guidance was associated with a 2.4-day reduction in antibiotic exposure (5.7 versus 8.1 days, 95% CI -2.71 to -2.15, P < 0.001) and lower risk of antibiotic-related side effects (16.3% versus 22.1%, adjusted OR 0.68, 95% CI 0.57 to 0.82, P < 0.001). Length of hospital stay and intensive care unit stay were similar in both groups. A sensitivity aggregate-data analysis based on all 32 eligible trials showed similar results. AUTHORS' CONCLUSIONS: This updated meta-analysis of individual participant data from 12 countries shows that the use of procalcitonin to guide initiation and duration of antibiotic treatment results in lower risks of mortality, lower antibiotic consumption, and lower risk for antibiotic-related side effects. Results were similar for different clinical settings and types of ARIs, thus supporting the use of procalcitonin in the context of antibiotic stewardship in people with ARIs. Future high-quality research is needed to confirm the results in immunosuppressed patients and patients with non-respiratory infections.


Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/tratamento farmacológico , Calcitonina/sangue , Precursores de Proteínas/sangue , Infecções Respiratórias/tratamento farmacológico , Doença Aguda , Antibacterianos/efeitos adversos , Infecções Bacterianas/sangue , Infecções Bacterianas/mortalidade , Biomarcadores/sangue , Peptídeo Relacionado com Gene de Calcitonina , Causas de Morte , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções Respiratórias/sangue , Infecções Respiratórias/mortalidade , Falha de Tratamento
13.
Eur Heart J ; 38(31): 2382-2385, 2017 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-28821171
14.
J Shoulder Elbow Surg ; 26(10): 1756-1764, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28689828

RESUMO

BACKGROUND: The number of total shoulder arthroplasties has increased in the past years, with encouraging results. However, the survival of anatomic total shoulder arthroplasty (aTSA) is lower compared with that of knee and hip replacements. Wear-associated problems like loosening are well-known causes of long-term failure of aTSA. The main purpose of this study was to investigate the wear behavior of ceramic-polyethylene bearings compared with the standard metal-polyethylene bearings. Because there is a lack of valid experimental wear testing methods, the secondary aim was to develop a validated wear simulation. METHODS: The wear assessment was performed using a force-controlled joint simulator for 3 × 106 cycles, and polyethylene wear was assessed gravimetrically and by particle analysis. Kinetic and kinematic data were adopted from in vivo loading measurements and from several clinical studies on shoulder joint kinematics. The reaction of the rotator cuff was simulated on the basis of a virtual soft tissue model. As activity, an abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an anteversion-retroversion has been chosen. RESULTS: The studied aTSA resulted in a polyethylene wear rate of 62.75 ± 1.60 mg/106 cycles in combination with metallic heads. The ceramic heads significantly reduced the wear rate by 26.7% to 45.99 ± 1.31 mg/106. There were no relevant differences in terms of the particle characteristics. CONCLUSION: This is the first study that experimentally studied the wear behavior of aTSA based on patient-related and biomechanical data under load-controlled conditions. Regarding polyethylene wear, the analyzed aTSA could benefit from ceramic humeral heads.


Assuntos
Artroplastia do Ombro/instrumentação , Desenho de Prótese , Prótese de Ombro , Fenômenos Biomecânicos , Cerâmica , Análise de Falha de Equipamento , Humanos , Cabeça do Úmero/cirurgia , Modelos Biológicos , Polietileno , Manguito Rotador/cirurgia
15.
J Arthroplasty ; 32(10): 3191-3199, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28552447

RESUMO

BACKGROUND: Taper corrosion has been identified to be a major concern in total hip arthroplasty during the past years. So far, the mechanisms that lead to taper corrosion in modular taper junctions are not fully understood. However, it has been shown that corrosion is also influenced by the geometry and topography of the taper, and these parameters vary among the implant manufacturers. The purpose of this study was to investigate the variations of common stem and head tapers regarding design and surface characteristics. METHODS: An analysis of selected commercially available 12/14 stem and head tapers was performed. As geometric parameters, the taper angle, the opening taper diameter, and the taper length were measured using a coordinate measuring machine. Several topographic parameters were determined using a tactile roughness measurement instrument. RESULTS: Although all investigated tapers are so-called 12/14 tapers, this study showed that the stem and head tapers differ among the manufacturers. The stem tapers were clearly different in both geometry and topography, and the range in variation of the topographic parameter was greater than it was for the geometric parameter. In contrast, the head tapers were different in their geometry, although not in topography. CONCLUSION: Ultimately, this study provides an overview on the characteristics and variations of modular hip taper connections, and in addition, a new classification system regarding the surface finish is presented. These findings could be further considered in experimental corrosion or retrieval studies.


Assuntos
Prótese de Quadril/estatística & dados numéricos , Desenho de Prótese/estatística & dados numéricos , Artroplastia de Quadril/instrumentação , Corrosão , Humanos
17.
Eur J Heart Fail ; 18(5): 482-9, 2016 05.
Artigo em Inglês | MEDLINE | ID: mdl-27071916

RESUMO

Composite endpoints are commonly used as the primary measure of efficacy in heart failure clinical trials to assess the overall treatment effect and to increase the efficiency of trials. Clinical trials still must enrol large numbers of patients to accrue a sufficient number of outcome events and have adequate power to draw conclusions about the efficacy and safety of new treatments for heart failure. Additionally, the societal and health system perspectives on heart failure have raised interest in ascertaining the effects of therapy on outcomes such as repeat hospitalization and the patient's burden of disease. Thus, novel methods for using composite endpoints in clinical trials (e.g. clinical status composite endpoints, recurrent event analyses) are being applied in current and planned trials. Endpoints that measure functional status or reflect the patient experience are important but used cautiously because heart failure treatments may improve function yet have adverse effects on mortality. This paper discusses the use of traditional and new composite endpoints, identifies qualities of robust composites, and outlines opportunities for future research.


Assuntos
Insuficiência Cardíaca/terapia , Hospitalização , Mortalidade , Atividades Cotidianas , Causas de Morte , Ensaios Clínicos como Assunto , Humanos , Qualidade de Vida , Resultado do Tratamento
18.
Ger Med Sci ; 13: Doc19, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26609286

RESUMO

In 2010, under the guidance of the DGAI (German Society of Anaesthesiology and Intensive Care Medicine) and DIVI (German Interdisciplinary Association for Intensive Care and Emergency Medicine), twelve German medical societies published the "Evidence- and Consensus-based Guidelines on the Management of Analgesia, Sedation and Delirium in Intensive Care". Since then, several new studies and publications have considerably increased the body of evidence, including the new recommendations from the American College of Critical Care Medicine (ACCM) in conjunction with Society of Critical Care Medicine (SCCM) and American Society of Health-System Pharmacists (ASHP) from 2013. For this update, a major restructuring and extension of the guidelines were needed in order to cover new aspects of treatment, such as sleep and anxiety management. The literature was systematically searched and evaluated using the criteria of the Oxford Center of Evidence Based Medicine. The body of evidence used to formulate these recommendations was reviewed and approved by representatives of 17 national societies. Three grades of recommendation were used as follows: Grade "A" (strong recommendation), Grade "B" (recommendation) and Grade "0" (open recommendation). The result is a comprehensive, interdisciplinary, evidence and consensus-based set of level 3 guidelines. This publication was designed for all ICU professionals, and takes into account all critically ill patient populations. It represents a guide to symptom-oriented prevention, diagnosis, and treatment of delirium, anxiety, stress, and protocol-based analgesia, sedation, and sleep-management in intensive care medicine.


Assuntos
Analgesia/normas , Sedação Consciente/normas , Cuidados Críticos/normas , Sedação Profunda/normas , Delírio/tratamento farmacológico , Ansiedade/diagnóstico , Ansiedade/tratamento farmacológico , Consenso , Delírio/diagnóstico , Delírio/terapia , Medicina Baseada em Evidências , Humanos , Hipnóticos e Sedativos/uso terapêutico , Sono , Estresse Psicológico/diagnóstico , Estresse Psicológico/tratamento farmacológico
19.
Crit Care ; 19: 74, 2015 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-25887979

RESUMO

INTRODUCTION: Whether the inflammatory biomarker procalcitonin provides prognostic information across clinical settings and different acute respiratory tract infections (ARIs) is poorly understood. In the present study, we investigated the prognostic value of admission procalcitonin levels to predict adverse clinical outcome in a large ARI population. METHODS: We analysed data from 14 trials and 4,211 ARI patients to study associations of admission procalcitonin levels and setting specific treatment failure and mortality alone at 30 days. We used multivariable hierarchical logistic regression and conducted sensitivity analyses stratified by clinical settings and ARI diagnoses to assess the results' consistency. RESULTS: Overall, 864 patients (20.5%) experienced treatment failure and 252 (6.0%) died. The ability of procalcitonin to differentiate patients with from those without treatment failure was highest in the emergency department setting (treatment failure area under the curve (AUC): 0.64 (95% confidence interval (CI): 0.61, 0.67), adjusted odds ratio (OR): 1.85 (95% CI: 1.61, 2.12), P <0.001; and mortality AUC: 0.67 (95% CI: 0.63, 0.71), adjusted OR: 1.82 (95% CI: 1.45, 2.29), P <0.001). In lower respiratory tract infections, procalcitonin was a good predictor of identifying patients at risk for mortality (AUC: 0.71 (95% CI: 0.68, 0.74), adjusted OR: 2.13 (95% CI: 1.82, 2.49), P <0.001). In primary care and intensive care unit patients, no significant association of initial procalcitonin levels and outcome was found. CONCLUSIONS: Admission procalcitonin levels are associated with setting specific treatment failure and provide the most prognostic information regarding ARI in the emergency department setting.


Assuntos
Calcitonina/sangue , Precursores de Proteínas/sangue , Infecções Respiratórias/mortalidade , Doença Aguda , Idoso , Biomarcadores/sangue , Peptídeo Relacionado com Gene de Calcitonina , Serviço Hospitalar de Emergência , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Prognóstico , Infecções Respiratórias/sangue , Infecções Respiratórias/tratamento farmacológico , Falha de Tratamento
20.
Clin Chem Lab Med ; 53(4): 583-92, 2015 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-25581762

RESUMO

BACKGROUND: Whether or not antibiotic stewardship protocols based on procalcitonin levels results in cost savings remains unclear. Herein, our objective was to assess the economic impact of adopting procalcitonin testing among patients with suspected acute respiratory tract infection (ARI) from the perspective of a typical US integrated delivery network (IDN) with a 1,000,000 member catchment area or enrollment. METHODS: To conduct an economic evaluation of procalcitonin testing versus usual care we built a cost-impact model based on patient-level meta-analysis data of randomized trials. The meta-analytic data was adapted to the US setting by applying the meta-analytic results to US lengths of stay, costs, and practice patterns. We estimated the annual ARI visit rate for the one million member cohort, by setting (inpatient, ICU, outpatient) and ARI diagnosis. RESULTS: In the inpatient setting, the costs of procalcitonin-guided compared to usual care for the one million member cohort was $2,083,545, compared to $2,780,322, resulting in net savings of nearly $700,000 to the IDN for 2014. In the ICU and outpatient settings, savings were $73,326 and $5,329,824, respectively, summing up to overall net savings of $6,099,927 for the cohort. RESULTS were robust for all ARI diagnoses. For the whole US insured population, procalcitonin-guided care would result in $1.6 billion in savings annually. CONCLUSIONS: Our results show substantial savings associated with procalcitonin protocols of ARI across common US treatment settings mainly by direct reduction in unnecessary antibiotic utilization. These results are robust to changes in key parameters, and the savings can be achieved without any negative impact on treatment outcomes.


Assuntos
Antibacterianos/uso terapêutico , Análise Química do Sangue/economia , Calcitonina/sangue , Assistência à Saúde/economia , Precursores de Proteínas/sangue , Infecções Respiratórias/sangue , Infecções Respiratórias/tratamento farmacológico , Doença Aguda , Peptídeo Relacionado com Gene de Calcitonina , Análise Custo-Benefício , Humanos , Pacientes Internados , Tempo de Internação/economia , Metanálise como Assunto , Infecções Respiratórias/economia , Estados Unidos
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