RESUMO
BACKGROUND: Chronic prurigo (CPG) is known as a high burdensome disease characterized by severe pruritus and multiple pruriginous lesions. Interestingly, the disease-specific burden is not well established and there are no data which compare the impact of CPG with chronic pruritus (CP) on non-lesional skin (CP-NL). OBJECTIVES: To address this issue, we analysed datasets from 4484 patients with either CPG or CP-NL. METHODS: Demographic medical data and additional information collected by validated patient reported outcome tools were analysed. The visual analogue scale and numerical rating scale (NRS) were used for assessing the pruritus intensity, the ItchyQoL for patients' quality of life, the Hospital Anxiety and Depression Scale and the Patient Needs Questionnaire' as a part of Patient Benefit Index for Pruritus for measuring the importance of 27 patient needs in terms of treatment goals. The Neuroderm questionnaire was used to assess the history of pruritus characteristics and the impact on sleep. RESULTS: Patients with CPG suffered longer and with a higher intensity from pruritus [NRS worst the last 24 h, CPG 6.0 (4.0;8.0) vs. CP-NL 3.0 (5.0;7.0), P < 0.001]. In them, pruritus occurred more often and the whole day and night which led to more loss in sleeping hours [CPG 3.0 h (2.0;4.0) vs. CP-NL 2.0 h (1.0;4.0), P < 0.001]. Patients with CPG showed higher scores for depression [HADS-D, CPG 6.0 (3.0;10.0) vs. CP-NL 5.0 (2.0;8.0), P < 0.001], more impaired quality of life [ItchyQol; CPG: 72.6 (61.6;83.6) vs. CP-NL 59.4 (48.4;70.4), P < 0.001] and higher weighted needs in the predefined treatment goals. DISCUSSION: Not only the presence of severe pruritus and pruriginous lesions but also sleep disorders and other mental symptoms may contribute to a higher burden in patients with CPG when compared with patients with CP-NL.
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Prurigo , Doença Crônica , Humanos , Prurigo/complicações , Prurigo/epidemiologia , Prurido/epidemiologia , Prurido/etiologia , Qualidade de Vida , Estudos RetrospectivosRESUMO
BACKGROUND: Chronic pruritus (CP) is a subjective symptom, and it is necessary to assess its intensity with validated patient-reported outcome tools in order to allow determination of the treatment course. OBJECTIVES: So far, the itch intensity scales were validated in small cohorts and in single languages. Here, we report the validation of the numerical rating scale, the verbal rating scale and the visual analogue scale for the worst and average pruritus intensity in the last 24h in several languages across Europe and across different pruritic dermatoses. METHODS: After professional translation, the intensity scales were digitized for use as a tablet computer application. Validation was performed in clinics for Dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. RESULTS: A total of 547 patients with contact dermatitis, chronic nodular prurigo, psoriasis vulgaris, lichen planus or cutaneous T-cell lymphoma were included. The intensity scales showed a high level of reproducibility and inter-correlations with each other. The correlation with the Dermatology Life Quality Index was weak to strong in nearly all countries and dermatoses with the exception of France and patients with chronic nodular prurigo, for which no statistically significant correlations were found. CONCLUSIONS: The numerical rating scale, the verbal rating scale und the visual analogue scales are valid instruments with good reproducibility and internal consistency in German (Germany, Austria, Switzerland), French, Italian, Polish, Russian, Spanish and Turkish for different pruritic dermatoses. VAS worst was the best reproducible and consistent measuring instrument in all countries.
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Prurido , Qualidade de Vida , Áustria , Europa (Continente) , França , Alemanha , Humanos , Itália , Polônia , Estudos Prospectivos , Prurido/diagnóstico , Prurido/epidemiologia , Reprodutibilidade dos Testes , Federação Russa , Índice de Gravidade de Doença , Espanha , Inquéritos e Questionários , Suíça/epidemiologia , TurquiaRESUMO
BACKGROUND: Chronic nodular prurigo (CNPG) is a condition characterized by chronic itch, a prolonged scratching behaviour and the presence of pruriginous nodules. A comprehensive understanding of this condition, especially regarding its clinical characteristics and impact on quality of life is still lacking. OBJECTIVES: Aim of this pan-European multicentre cross-sectional study was to establish the clinical profile of CNPG, including its associated burden. METHODS: Fifteen centres from 12 European countries recruited CNPG patients presenting at the centre or using the centres' own databases. Patients were asked to complete a questionnaire in paper or electronic format. Demography, current co-morbidities, underlying disease, itch intensity, additional sensory symptoms, quality of life, highest burden and emotional experience of itch were assessed. RESULTS: A total of 509 patients (210 male, median age: 64 years [52; 72]) were enrolled. Of these, 406 reported itch and CNPG lesions in the previous 7 days and qualified to complete the whole questionnaire. We recorded moderate to severe worst itch intensity scores in the previous 24 h. Scores were higher in patients with lower educational levels and those coming from Eastern or Southern Europe. Most patients experience itch often or always (71%) and report that their everyday life is negatively affected (53%). Itch intensity was considered to be the most burdensome aspect of the disease by 49% of the patients, followed by the visibility of skin lesions (21%) and bleeding of lesions (21%). The majority of patients was unaware of an underlying condition contributing to CNPG (64%), while psychiatric diseases were the conditions most often mentioned in association with CNPG (19%). CONCLUSIONS: This multicentre cross-sectional study shows that itch is the dominant symptom in CNPG and reveals that the profile of the disease is similar throughout Europe.
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Prurigo , Doença Crônica , Estudos Transversais , Europa (Continente)/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Prurigo/epidemiologia , Prurido/epidemiologia , Prurido/etiologia , Qualidade de VidaRESUMO
BACKGROUND: Chronic pruritus (CP) is a frequently occurring symptom in inflammatory dermatoses, causing a high burden and limitations to health-related quality of life (HRQoL). OBJECTIVE: The ItchyQoL was developed to assess the impairment to HRQoL in patients with CP. However, it has only been validated in English and German. Here, we report the validation in several languages across Europe. METHODS: After professional translation, the versions of ItchyQoL were digitized for use as a tablet application. Validation was performed in clinics for dermatology in Austria, France, Germany, Italy, Poland, Russia, Spain, Switzerland and Turkey. RESULTS: Five hundred and thirty-five patients with either contact dermatitis, chronic prurigo - nodular type, psoriasis vulgaris, lichen planus or mycosis fungoides/Sézary syndrome and with CP ≥ 3 on the numerical rating scale were included. ItchyQoL showed a high level of consistency (Cronbach's-α, all: 0.95) and test-retest reliability (intraclass correlation: 0.91). It strongly correlated with the Dermatology Life Quality Index (r = 0.72, P < 0.001) and moderately correlated with itch intensity scales in the study population (visual analogue scale r = 0.46; numerical rating scale r = 0.51; verbal rating scale r = 0.51, for all: P < 0.001). CONCLUSION: ItchyQoL is now also validated in French, Italian, Polish, Russian, Spanish and Turkish and can be used in clinical trials in countries speaking these languages.
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Prurido/diagnóstico , Prurido/psicologia , Qualidade de Vida/psicologia , Dermatopatias/patologia , Dermatopatias/psicologia , Adulto , Idoso , Estudos Transversais , Europa (Continente) , Feminino , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , Psicometria , Medição de Risco , Índice de Gravidade de Doença , Adulto JovemRESUMO
BACKGROUND: The term prurigo has been used for many decades in dermatology without clear definition, and currently used terminology of prurigo is inconsistent and confusing. Especially, itch-related prurigo remains unexplored regarding the epidemiology, clinical profile, natural course, underlying causes, available treatments and economic burden, although burdensome and difficult to treat. OBJECTIVE: To address these issues, the multicentre European Prurigo Project (EPP) was designed to increase knowledge on chronic prurigo (CPG). In the first step, European experts of the EADV Task Force Pruritus (TFP) aimed to achieve a consensus on the definition, classification and terminology of CPG. Additionally, procedures of the cross-sectional EPP were discussed and agreed upon. METHODS: Discussions and surveys between members of the TFP served as basis for a consensus conference. Using the Delphi method, consensus was defined as an agreement ≥75% among the present members. RESULTS: Twenty-four members of the TFP participated in the consensus conference. Experts consented that CPG should be used as an umbrella term for the range of clinical manifestations (e.g. papular, nodular, plaque or umbilicated types). CPG is considered a distinct disease defined by the presence of chronic pruritus for ≥6 weeks, history and/or signs of repeated scratching and multiple localized/generalized pruriginous skin lesions (whitish or pink papules, nodules and/or plaques). CPG occurs due to a neuronal sensitization to itch and the development of an itch-scratch cycle. CONCLUSION: This new definition and terminology of CPG should be implemented in dermatology to harmonize communication in the clinical routine, clinical trials and scientific literature. Acute/subacute forms of prurigo are separated entities, which need to be differentiated from CPG and will be discussed in a next step. In the near future, the cross-sectional EPP will provide relevant clinical data on various aspects of CPG leading to new directions in the scientific investigation of CGP.
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Prurigo/classificação , Terminologia como Assunto , Doença Crônica , Consenso , Técnica Delphi , HumanosRESUMO
OBJECTIVE/BACKGROUND: The study aim was to determine whether patient safety for non-ruptured abdominal aortic aneurysm (nrAAA) repair has changed between 1999 and 2010 in a large German cohort. METHODS: The data source was the prospective quality assurance registry of the German Vascular Society from 1999 to 2010. Patient characteristics, surgical techniques (open aortic repair [OAR], endovascular aortic repair [EVAR]), procedural time and outcomes, including the length of hospital stay (LOS), were analysed using the Cochran-Armitage test for binary parameters and Spearman's correlation coefficient for quantitative parameters. RESULTS: A total of 36,594 operations (23,037 OAR, 13,557 EVAR) for infrarenal nrAAA in 201 hospitals in Germany were investigated. Patients' mean age increased from 69.6 to 72.0 years (p < .001). The rate of patients with American Society of Anesthesiologists scores of 3 or 4 increased (p < .001). Use of EVAR increased (1999: 16.7%; 2010: 62.7%; p < .001), and since 2009, EVAR has been more frequently used than OAR. The overall in hospital mortality decreased from 3.1% in 1999 to 2.3% in 2010 (p < .001). There were no temporal trends for mortality rates for EVAR (p = .233) or OAR (p = .281) when considered separately. Cardiac (1999: 8.1%; 2010: 5.1%; p < .001) and pulmonary (1999: 7.8%; 2010: 4.8%; p < .001) complications decreased. The rate of post-operative renal failure increased (1999: 3.6%; 2010 4.1%; p = .017), without increasing the rate of patients needing dialysis (1999: 1.7%; 2010: 1.7%; p = .171). The median LOS decreased from 17 days in 1999 to 10 days in 2010 (p < .001). CONCLUSION: This study shows significantly improved post-procedural in hospital outcomes and decreased use of resources for nrAAA repair. This trend can probably be attributed to the implementation of EVAR as a standard technique, but some trends could also possibly be explained by a change in the remuneration system. The main limitation of the registry is the lack of internal and external validation. However, in hospital patient safety for AAA repair seems to have improved significantly in the participating hospitals.
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Aneurisma da Aorta Abdominal/cirurgia , Implante de Prótese Vascular/tendências , Procedimentos Endovasculares/tendências , Segurança do Paciente , Idoso , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/mortalidade , Implante de Prótese Vascular/efeitos adversos , Implante de Prótese Vascular/mortalidade , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/mortalidade , Feminino , Alemanha , Mortalidade Hospitalar/tendências , Humanos , Tempo de Internação/tendências , Masculino , Pessoa de Meia-Idade , Melhoria de Qualidade/tendências , Indicadores de Qualidade em Assistência à Saúde/tendências , Sistema de Registros , Fatores de Risco , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: The challenges of modern wound management, such as the treatment of chronic wounds and their phase-specific handling, are demanding and require optimally adapted therapeutic measures. The principles of moist wound care as well as an adequate debridement have priority here. To support these necessary measures, different options are available, e.g., a new product group operating across several wound phases. OBJECTIVE: A new treatment principle in modern wound management based on an expert consensus is presented. METHODS: On the basis of clinical experience reports and published evidence, the current and new principles of wound treatment were discussed in a panel of experts and formulated as a consensus statement. RESULTS: Enzyme alginogels represent a combination of agents that allow phase-specific wound care. They exhibit autolytic, absorbent, and antimicrobial properties and simultaneously cover three components of wound management based on the TIME framework. Thus, according to the experts, they differ from other wound healing products and can be classified in a distinct product group. Clinical studies, as well as clinical experiences, provide evidence for the efficacy of enzyme alginogels. DISCUSSION: According to the experts, the potential of enzyme alginogels used considering the principles of moist wound care, comprises the three-fold effect (continuous and significantly simplified debridement, maintaining a moist wound environment and antimicrobial effect without cytotoxicity), the ease of use, and the flexible application. In addition, the flexibility of the product class regarding frequency of application, duration of treatment and combinability with secondary dressings, are of economic benefit in the health care sector.
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Alginatos/administração & dosagem , Desbridamento/normas , Dermatologia/normas , Prova Pericial/normas , Oxirredutases/administração & dosagem , Cicatrização/efeitos dos fármacos , Antibacterianos/administração & dosagem , Bandagens , Terapia Combinada/métodos , Terapia Combinada/normas , Desbridamento/métodos , Medicina Baseada em Evidências , Alemanha , Humanos , Lacerações/diagnóstico , Lacerações/terapia , Guias de Prática Clínica como Assunto , Resultado do TratamentoRESUMO
Venous leg ulcer (VLU) counts among the most common chronic wounds in Europe. Treatment is lengthy, cumbersome and costly, and there is a high rate of recurrence. This review shows the measures that should be offered to every patient with healed VLU to permanently prevent recurrence. To prevent VLU in case of varicose veins, the progression of chronic venous insufficiency (CVI) has to be stopped. There is convincing evidence that the effective treatment of varicose veins reduces the recurrence rate in patients with VLU. In patients with post-thrombotic syndrome (PTS), further thrombosis should be prevented through targeted prophylaxis of new thromboembolic events. The benefit of endovascular revascularization on the VLU recurrence rate in patients with post-thrombotic damage in the pelvic veins has not been proven in clinical studies. On the other hand, it has been clearly demonstrated in several studies that compression therapy is the basic procedure for the prevention of recurrent VLU in patients with varicose veins or PTS, regardless of whether other measures have been implemented or not. Good adherence in patients with compression therapy is more important than choosing the highest possible compression class. Future efforts for patients with VLU must aim to provide therapists with tools and treatment strategies to guide their patients and to increase patients' acceptance and understanding of the importance of self-management, in particular regarding compression therapy for the prevention of recurrent VLU.
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Prevenção Secundária , Úlcera Varicosa/prevenção & controle , Cooperação do Paciente , Educação de Pacientes como Assunto , Autocuidado , Meias de Compressão , Varizes/complicações , Varizes/etiologia , Varizes/fisiopatologia , Varizes/prevenção & controle , Insuficiência Venosa/complicações , Insuficiência Venosa/etiologia , Insuficiência Venosa/fisiopatologia , Insuficiência Venosa/prevenção & controle , Cicatrização/fisiologiaRESUMO
PURPOSE: An estimated 350,000 varicose vein (VV) surgical procedures are performed in Germany each year, with annual treatment costs amounting to about 800 million Euro. To evaluate the outcome quality of this treatment, we examined the intraoperative and postoperative complication rates on record in the VV surgery quality assessment (QA) registry of the German Society for Vascular Surgery (GSVS). METHODS: Data on 89,647 patients (27,463 men, 62,184 women; average age 52.8 years, range 15-96 years) collected in the GSVS varicose surgery QA registry between 2001 and 2009 were analyzed. In these patients, 95,214 surgical procedures were performed on 105,296 limbs. Complication rates were correlated with the type of VV surgical procedure, with whether surgery was performed on an inpatient or outpatient basis, and with the CEAP classification (C stage) and American Society of Anaesthesiologists' (ASA) stage at the time of surgery. Statistical analyses were performed using a chi-square test, a Cochrane-Armitage test, and an odds ratio calculation. RESULTS: Intraoperative and postoperative complication was low (0.18 and 0.43 %, respectively), being the lowest for radiofrequency ablation (0.25 %) but not differing significantly from those for endovenous laser therapy and high ligation and stripping. General complications occurred in 0.67 % of outpatients and in 0.25 % of inpatients, a highly significant statistical difference (p < 0.0001, chi-square test). With regard to C stage, the higher the stage, the higher the local complication rate. A clear correlation was also found between preoperative ASA stage and postoperative complication rates: for ASA stages I and II, the complication rates were 0.2 and 0.5 %, respectively, increasing for ASA stage III to 1.2 % and for ASA IV to 2.2 %. The differences between the ASA classes were highly statistically significant (p < 0.0001, Cochrane-Armitage test) CONCLUSIONS: Outcome quality as reflected in the intraoperative and postoperative complication rates was very good for all patients undergoing inpatient or outpatient VV surgery. Data from the GSVS QA registry shows that VV surgery is performed with very good perioperative results in specialized centers in Germany.
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Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Qualidade da Assistência à Saúde , Varizes/cirurgia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ablação por Cateter/efeitos adversos , Feminino , Alemanha/epidemiologia , Humanos , Terapia a Laser/efeitos adversos , Masculino , Pessoa de Meia-Idade , Varizes/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Chronic pruritus is a frequently occurring symptom of various dermatoses that causes a high burden and impaired quality of life. An effective anti pruritic therapy is important for the patient, but its effectiveness is difficult to evaluate. Diverse methods and interpretations of pruritic metrics are utilized in clinical trials and the daily clinical practice in different countries, resulting in difficulties comparing collected data. METHODS: We founded a European Network on Assessment of Severity and Burden of Pruritus (PruNet) that is supported by the EADV. PruNet consists of 28 experts from 15 EU countries (21 dermatologists, 5 medical informaticists, 2 psychologists) and aims to unify the assessment of itch in routine dermatological care. Following a preliminary survey, a consensus conference was held in order to agree upon the prioritization of patient-reported outcome tools. RESULTS: Through utilizing the Delphi method, it was agreed that tools for measuring itch intensity (ex. the visual analogue scale) and quality of life (ex. ItchyQoL) are of primary importance and should urgently be foremost validated. CONCLUSION: The validation and harmonization of standards are needed for the improvement of quality care for patients suffering from pruritic dermatoses. This summer, the first validation studies in several EADV member countries already began.
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Prurido/fisiopatologia , Índice de Gravidade de Doença , Doença Crônica , Europa (Continente) , Humanos , Prurido/tratamento farmacológico , Qualidade de VidaRESUMO
UNLABELLED: Chronic wounds are an increasing problem in our ageing population and can arise in many different ways. Over the past decades it has become evident that sufficient oxygen supply is an essential factor of appropriate wound healing. Sustained oxygen deficit has a detrimental impact on wound healing, especially for patients with chronic wounds. This has been proven for wounds associated with peripheral arterial occlusive disease (PAOD) and diabetic foot ulcers (particularly in combination with PAOD). However, this is still under debate for other primary diseases. In the past few years several different new therapeutic approaches for topical oxygen therapies have been developed to support wound healing. These tend to fall into one of four categories: (1) delivery of pure oxygen either under pressurised or (2) ambient condition, (3) chemical release of oxygen via an enzymatic reaction or (4) increase of oxygen by facilitated diffusion using oxygen binding and releasing molecules. In this review article, the available therapeutic topical oxygen-delivering approaches and their impact on wound healing are presented and critically discussed. A summary of clinical data, daily treatment recommendations and practicability is provided. DECLARATION OF INTEREST: J. Dissemond received an honorarium for lectures, advisory boards and/or clinical studies from the following companies: 3M, B. Braun, BSN, Coloplast, Convatec, Draco, Hartmann, KCI, Lohmann&Rauscher, Medoderm, Merz, Sastomed, Systagenix, UCB-Pharma, Urgo. K. Kröger received an honorarium for lectures, advisory boards and/or clinical studies from the following companies: Bayer, Sanofi, GSK, Hartmann, Sastomed, UCB-Pharma, Urgo. M. Storck received an honorarium for lectures for the following companies: KCI, Systagenix, and UCB-Pharma. A. Risse received an honorarium for lectures, advisory boards and/or clinical studies from the following companies: Bracco, Coloplast, Draco, Lilly Deutschland, NovoNordisk, Sastomed, Urgo. P. Engels received an honorarium for lectures, and consulting from the following companies: Sastomed, Oculus.
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Úlcera da Perna/terapia , Oxigênio/administração & dosagem , Pé Diabético/terapia , Humanos , Oxigenoterapia Hiperbárica , Úlcera por Pressão/terapiaRESUMO
Diagnostic imaging is crucial in the work-up of acute aortic diseases. Current imaging algorithms enable radiologists differentiating the various entities with subsequent clinically relevant treatment options. Within this educational overview we focus on non-traumatic acute aortic disease. Recent developments of cross sectional imaging are summarized. As for acute aortic disease, we discuss dissections, intramural hematoma, penetrating aortic ulcer, and aortitis. Current treatment options are presented.
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Angiografia/métodos , Doenças da Aorta/diagnóstico , Doenças da Aorta/terapia , Angiografia por Ressonância Magnética/métodos , Tomografia por Emissão de Pósitrons/métodos , Tomografia Computadorizada por Raios X/métodos , Doença Aguda , Aorta , Diagnóstico Diferencial , Medicina Baseada em Evidências , Humanos , PrognósticoRESUMO
Carotid endarterectomy (CEA) has been evaluated in many prospective randomized studies. After the introduction of carotid stenting (CAS) an alternative treatment is now available for treatment of extracranial carotid stenoses. Comparative studies have been carried out to compare these two modalities. There are two general methods for operative reconstruction available: patch angioplasty and endarterectomy. The results of the mandatory quality assurance registry between the time period 2003-2011 showed a reduction in complication rates, more operations in regional anesthesia and a higher percentage of eversion endarterectomy during the observation period. Since 2012 CAS is now also included in the national quality assurance program.
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Angioplastia/mortalidade , Angioplastia/estatística & dados numéricos , Estenose das Carótidas/mortalidade , Estenose das Carótidas/cirurgia , Endarterectomia das Carótidas/mortalidade , Endarterectomia das Carótidas/estatística & dados numéricos , Terapia Combinada/mortalidade , Terapia Combinada/estatística & dados numéricos , Medicina Baseada em Evidências , Humanos , Prevalência , Fatores de Risco , Taxa de Sobrevida , Resultado do TratamentoRESUMO
BACKGROUND: Today numerous products for wound care are available. A research-based evidence on which the clinician can base its selection, is still missing. In the guidelines randomized controlled trials (RCTs) have been left out. METHOD: In the overview three current RCT with products for the treatment of chronically venous ulcers will be presented. RESULTS AND CONCLUSIONS: The pre-mentioned studies show, that it is possible to provide a basis for evidence-based treatment in wound healing. The effective value ofa wound treatment based on the costs and benefits must be defined by the health system. But products, for which data from randomized trials exist, should be evaluated in a different way to products, for which there are no such data.
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Medicina Baseada em Evidências , Úlcera Varicosa/terapia , Biomarcadores , Análise Custo-Benefício/economia , Medicina Baseada em Evidências/economia , Humanos , Programas Nacionais de Saúde/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Úlcera Varicosa/economia , Cicatrização/fisiologiaRESUMO
This article summarizes the current study situation on treatment of asymptomatic carotid artery stenosis and discusses the evidence situation in the literature. The 10-year results of the ACST study have shown that in comparison to conservative treatment, carotid endarterectomy (CEA) has retained a positive long-term effect on the reduction of all forms of stroke. All multicenter randomized controlled trials comparing CEA with carotid artery stenting (CAS) and, in particular the SAPHIRE and CAVATAS studies, have in common that despite a basic evidence level of Ib, the case numbers of asymptomatic patients are too small for a conclusive therapy recommendation. In the overall assessment of the CREST study the resulting difference in the questionable endpoint of "perioperative myocardial infarction" in favor of the CAS methods, could not be confirmed for exclusively asymptomatic patients. In the long-term course of the CREST study, both methods were classified as equivalent, even when the 4year results of periprocedural and postprocedural stroke rates in the separate assessment of the asymptomatic study participants clearly favored the CEA. The results of the ACST-1 study showed an equivalent effect of both treatment methods with respect to all investigated endpoints; however, the unequal sizes of the groups in addition to the statistically insufficient case numbers put a question mark on the validity of the study results. The results of the ASCT-2 and CREST-2 studies are to be awaited, which also investigate the significance of "CEA versus CAS" (ASCT-2) and "CEA/CAS + best medical treatment (BMT) versus BMT alone" in only asymptomatic stenoses. The current S3 guidelines allow operative therapy to be considered in patients with a 60-99% asymptomatic carotid artery stenosis, because the risk of stroke is statistically significantly reduced.
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BACKGROUND: Patient-reported outcomes (PROs) are information provided directly by patients that helps in improving patient diagnosis and treatment. Validated translations of PROs can be used to treat international patients. Electronic systems and especially mobile devices provide a great opportunity for their collection; however, these systems are normally study-oriented and therefore single language, not scalable, and not interoperable. OBJECTIVES: This article reports the development of a multicenter, multilingual, and interoperable electronic PRO (ePRO) system and evaluates its user satisfaction in an international clinical study. METHODS: The ePRO named "MoPat2" was developed using Java 8 and jQuery Mobile 1.4.5. The system was evaluated in the context of the European dermatology project "European Network on Assessment of Severity and Burden of Pruritus"(PruNet), which aimed to unify the assessment of itch in routine dermatological care in Europe. Twenty-six clinicians and 468 patients from 8 European clinical centers were asked to complete a user satisfaction questionnaire regarding the use of MoPat2 with a tablet personal computer. The results were then analyzed and correlated with the age, gender, and language of the respondents. RESULTS: MoPat2 was enhanced with multilingual capabilities and is now able to conduct surveys in several languages, as well as store and display the results in the local language. The interviewed clinicians rated the system with an average score of 2.0 ("good") in a 1 to 5 Likert scale. Note that 93.9% of the patients (439 of 468) reported having got on well using the system and 88.9% (416 of 456) would be willing to further use it. The age of the patients not willing to further use MoPat2 was, in average, considerably higher than the age of patients willing to use the system. CONCLUSIONS: This study represents the first use of an ePRO system for the collection of multilingual PROs in an international, multicenter setting. MoPat2 has been evaluated by both clinicians and patients in the context of a European dermatological study, resulting in a high user satisfaction. The system will be further developed to include new features such as patient follow-ups outside of the clinical setting.
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Informática Médica , Multilinguismo , Medidas de Resultados Relatados pelo Paciente , Europa (Continente) , Humanos , Pacientes Ambulatoriais , Satisfação do Paciente , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: The Kerecis™ Omega3 Wound matrix is a decellularized skin matrix derived from fish skin and represents an innovative concept to achieve wound healing. The aim of this study was to report the cumulative experience of three centers for vascular surgery regarding use of the Omega3 Wound matrix in selected patients with complicated wounds. MATERIAL AND METHODS: In this study 23 patients with 25 vascular and/or diabetes mellitus-associated complicated wounds and partially exposed bony segments were treated with the Omega3 Wound matrix in three vascular centers. In several patients, conventional wound treatment with vacuum therapy had previously been carried out sometimes over several weeks without durable success. Following initial debridement in the operating room, the matrix was applied and covered with a silicone mesh. In the further course, wound treatment was conducted on an outpatient setting if possible. RESULTS: In total 25 wounds were treated with localization at the level of the thigh (nâ¯= 2), the distal calf (nâ¯= 7), the forefoot (nâ¯= 14) and the hand (nâ¯= 2). The time to heal varied between 9 and 41 weeks and between 3 and 26 wound matrices were applied per wound. Interestingly, a reduction of analgesics intake was noted when the treatment with the Omega3 Wound matrix was initiated. CONCLUSION: The novel Omega3 Wound matrix in this study represented an effective treatment option in 25 complicated wounds. Further studies are necessary to evaluate the impact of the wound matrix on stimulation of granulation tissue and re-epithelialization as well as the potential antinociceptive and analgetic effects.
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In this article, current evidence-based treatment recommendations for acute and chronic lower limb ischemia will be presented considering the varied possibilities of endovascular techniques and open surgical vascular strategies. Beside presentation of the different therapeutic possibilities, advantages of the combination of both techniques will be described. Despite the BASIL trial, there are no prospective randomised controlled trials comparing endovascular and open surgical interventions. Different therapeutic rules along the different vascular segments will be discussed for both acute and chronic peripheral arterial disease. Generally it can be stated that aortoiliac revascularization for chronic obstructions is increasingly being carried out by endovascular means or hybrid procedures using a minimally invasive femoral approach, whereas acute occlusions in this vascular segment are still treated with open surgical techniques (Fogarty balloon thrombectomy). In the infrainguinal region, endovascular therapeutic strategies are gaining favor. However, multilevel occlusions and long-segment obstructions in the femoral and popliteal segment are still treated by bypass procedures. Acute ischemia in the infrainguinal segment is increasingly treated with endovascular methods (local thrombolysis and percutaneous thrombectomy).
Assuntos
Angioplastia com Balão , Arteriopatias Oclusivas/cirurgia , Arteriopatias Oclusivas/terapia , Isquemia/cirurgia , Isquemia/terapia , Perna (Membro)/irrigação sanguínea , Doenças Vasculares Periféricas/cirurgia , Doenças Vasculares Periféricas/terapia , Stents , Doença Aguda , Angiografia , Arteriopatias Oclusivas/diagnóstico por imagem , Arteriopatias Oclusivas/tratamento farmacológico , Implante de Prótese Vascular , Embolectomia , Humanos , Isquemia/tratamento farmacológico , Perna (Membro)/diagnóstico por imagem , Estudos Multicêntricos como Assunto , Doenças Vasculares Periféricas/diagnóstico por imagem , Doenças Vasculares Periféricas/tratamento farmacológico , Doenças Vasculares Periféricas/etiologia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Trombectomia , Terapia Trombolítica/métodos , Tomografia Computadorizada por Raios XRESUMO
Primary malignant vascular tumors represent a rare cause of acute extremity ischemia. Due to unspecific symptoms the correct diagnosis is often delayed and confirmed in many cases as late as post mortem. Differential diagnosis of malignant vascular tumors should be considered in patients with acute ischemia, atypical history and absence of typical risk factors for vascular diseases. The overall prognosis of such tumors is poor. If possible, complete curative resection in combination with arterial reconstruction should be performed. Multimodal therapy has to be considered and discussed in appropriate tumor boards. We report a case of a 70-year-old male patient with acute ischemia and contained rupture of a pseudoaneurysm of the external iliac artery due to an undifferentiated high grade pleomorphic sarcoma. At the time of the primary operation, diffuse skeletal metastases were present but even detected postoperatively during staging. Therefore, no adjuvant or palliative therapy was initiated. In the postoperative course, recurrent non reversible ischemia was present followed by amputation of the right leg. The patient died 5 months after first operation. In the autopsy further metastases of lung and liver were found.
Assuntos
Falso Aneurisma/complicações , Aneurisma Roto/complicações , Aneurisma Ilíaco/complicações , Artéria Ilíaca , Isquemia/etiologia , Sarcoma/complicações , Trombose/complicações , Neoplasias Vasculares/complicações , Doença Aguda , Idoso , Falso Aneurisma/diagnóstico , Falso Aneurisma/patologia , Falso Aneurisma/cirurgia , Aneurisma Roto/diagnóstico , Aneurisma Roto/patologia , Aneurisma Roto/cirurgia , Angiografia Digital , Implante de Prótese Vascular , Evolução Fatal , Humanos , Aneurisma Ilíaco/diagnóstico , Aneurisma Ilíaco/patologia , Aneurisma Ilíaco/cirurgia , Artéria Ilíaca/patologia , Artéria Ilíaca/cirurgia , Isquemia/patologia , Isquemia/cirurgia , Perna (Membro)/irrigação sanguínea , Masculino , Polietilenotereftalatos , Sarcoma/diagnóstico , Sarcoma/patologia , Sarcoma/cirurgia , Trombose/diagnóstico , Trombose/patologia , Trombose/cirurgia , Neoplasias Vasculares/diagnóstico , Neoplasias Vasculares/patologia , Neoplasias Vasculares/cirurgiaRESUMO
AIM: In Germany, every surgical or endovascular procedure on the extracranial carotid artery is documented in a mandatory quality assurance registry. The purpose of this study is to describe the patient characteristics, the indications for treatment, and the short-term outcomes as well as to analyse the corresponding trends from 2003 to 2014. METHODS: Data on demographics, peri-procedural measures, and outcomes were extracted from the annual quality reports published by the Federal Agency for Quality Assurance and the Institute for Applied Quality Improvement and Research in Health Care. Data were available from 2003 to 2014 for carotid endarterectomy (CEA) and from 2012 to 2014 for carotid artery stenting (CAS). The primary outcome event of this study is any stroke or death until discharge from hospital. Temporal trends of categorical variables were statistically analysed using the Cochran-Armitage test for trend. RESULTS: Between 2003 and 2014, 309,405 CEAs and 18,047 CAS procedures were documented in the database; 68.1% of all patients were male. The mean age of patients treated with CEA increased from 68.9 years in 2003 to 70.9 years in 2014. The proportion of patients with ASA stages III to V increased from 65% to 71% in CEA, whereas it decreased from 44% to 41% in CAS patients. 53.1% of all CEAs were performed for asymptomatic patients (group A), 34.4% for symptomatic patients treated electively (group B), and 11.2% a in a collective group including other indications for CEA or CAS (such as recurrent stenosis, carotid aneurysms, emergency treatment due to stroke-in-evolution). The corresponding data for CAS are 49.3%, 26.1% and 26.3% respectively. In group B, the interval between the neurological index event and CEA decreased from 28 to 8 days (P<0.001). In patients treated with CAS, this interval was 9 days in 2012 (no further data available). On average, 67.1% and 48.2% of surgically treated patients as well as 77.8% and 69.8% of CAS patients were neurologically assessed before and after the procedure, respectively. From 2003 to 2014, CEA procedures were performed more frequently in locoregional anesthesia (10.1% to 29.1%, P<0.001). The same trend was observed for the application of the eversion technique (37.0% to 41.6%, P<0.001), the neurophysiological monitoring (49.8% to 61.8%, P<0.001), and the intra-procedural assessment of the treated artery (44.5% to 69.7%, P<0.001). In contrast, shunting was used less frequently (48.1% to 43.0%, P<0.001). Averagely 95.7% of all endovascular procedures were performed using stent-angioplasty. In 54.2% a protection device was used. Nitinol and bare metal stents were used in 74.1% and 21.4% of cases, respectively. The in-hospital rate of any stroke or death decreased from 2.0% to 1.1% in asymptomatic patients treated with CEA without a contralateral stenosis ≥75% or occlusion, P<0.001). In patients treated with CAS this rate did not increase (1.7% to 1.8%, p=0.909). The corresponding rates in CEA and CAS patients with severe contralateral stenosis or occlusion varied between 1.9%-3.1% and 2.2%-2.6%, respectively. In symptomatic patients (group B) with a stenosis of 50 percent or more, the rate of any stroke or death decreased significantly after CEA from 4.2% to 2.4% (P<0.001) and remained stable after CAS (3.9% to 3.5%, P=0.577). CONCLUSION: This report on 327,452 carotid procedures analysed one of the largest quality registries on CEA and CAS worldwide. Data indicate that treated patients became older and sicker, whereas in contrast, the in-hospital rates of stroke or death are decreasing over time.