Standardized definitions and clinical endpoints in trials investigating endovascular repair of aortic dissections.

OBJECTIVES Endovascular therapy is a rapidly expanding option for the treatment of patients with aortic dissection (AD) and various studies have been published. These trials, however, are often difficult to interpret and compare because they do not utilize uniform clinical endpoint definitions. METHODS The DEFINE Group is a collaborative effort of an ad hoc multidisciplinary team from various specialties involved in AD therapy in Europe and the United States. DEFINE's goal was to arrive at a broad based consensus for baseline and endpoint definitions in trials for endovascular therapy of various vascular pathologies. In this project, which started in December 2006, the individual team members reviewed the existing pertinent literature. Following this, a series of telephone conferences and face-to-face meetings were held to agree upon definitions. Input was also obtained from regulatory (United States Food and Drug Administration) and industry (device manufacturers with an interest in peripheral endovascular revascularization) stakeholders, respectively. RESULTS These efforts resulted in the present document containing proposed baseline and endpoint definitions for clinical and morphological outcomes. Although the consensus has inevitably included certain arbitrary consensus choices and compromises, adherence to these proposed standard definitions would provide consistency across future trials, thereby facilitating evaluation of clinical effectiveness and safety of various endovascular revascularization techniques. CONCLUSIONS This current document is based on a broad based consensus involving relevant stakeholders from the medical community, industry and regulatory bodies. It is proposed that the consensus document may have value for study design of future clinical trials in endovascular AD therapy as well as for regulatory purposes.

Corrective experiences in psychotherapy: Definitions, processes, consequences, and research directions

After 5 years of conceptualizing, investigating, and writing about corrective experiences (CEs), we (the authors of this chapter) met to talk about what we learned. In this chapter, we summarize our joint understanding of (a) the definition of CEs; (b) the contexts in which CEs occur; (c) client, therapist, and external factors that facilitate CEs; (d) the consequences of CEs; and (e) ideas for future theoretical, clinical, empirical, and training directions. As will become evident, the authors of this chapter, who represent a range of theoretical orientations, reached consensus on some CE-related topics but encountered controversy and lively debate about other topics. (PsycINFO Database Record (c) 2013 APA, all rights reserved)

Full and hat inductive definitions are equivalent in NBG

A new research project has, quite recently, been launched to clarify how different, from systems in second order number theory extending ACA 0, those in second order set theory extending NBG (as well as those in n + 3-th order number theory extending the so-called Bernays−Gödel expansion of full n + 2-order number theory etc.) are. In this article, we establish the equivalence between Δ10\bf-LFP and Δ10\bf-FP, which assert the existence of a least and of a (not necessarily least) fixed point, respectively, for positive elementary operators (or between Δn+20\bf-LFP and Δn+20\bf-FP). Our proof also shows the equivalence between ID 1 and ^ID1, both of which are defined in the standard way but with the starting theory PA replaced by ZFC (or full n + 2-th order number theory with global well-ordering).

Forcing for hat inductive definitions in arithmetic

By forcing, we give a direct interpretation of inline image into Avigad's inline image. To the best of the author's knowledge, this is one of the simplest applications of forcing to “real problems”.

Persistence of ultrasound synovitis in patients with rheumatoid arthritis fulfilling the DAS28 and/or the new ACR/EULAR RA remission definitions: results of an observational cohort study.

OBJECTIVE The primary aim of the study was to evaluate whether rheumatoid arthritis (RA) patients considered to be in remission according to clinical criteria sets still had persisting ultrasound (US) synovitis. We further intended to evaluate the capacity of our US score to discriminate between the patients with a clinically active disease versus those in remission. METHODS This is an observational study nested within the Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) rheumatoid arthritis cohort. A validated US score (SONAR score) based on a semi-quantitative B-mode and Doppler (PwD) score as part of the regular clinical workup by rheumatologists in different clinical settings was used. To define clinically relevant synovitis, the same score was applied to 38 healthy controls and the 90st percentile was used as cut-off for 'relevant' synovitis. RESULTS Three hundred and seven patients had at least one US examination and concomitant clinical information on disease activity. More than a third of patients in both DAS28 and ACR/EULAR remission showed significant gray scale synovitis (P=0.01 and 0.0002, respectively) and PwD activity (P=0.005 and 0.0005, respectively) when compared to controls. The capacity of US to discriminate between the two clinical remission groups and patients with active disease was only moderate. CONCLUSION This observational study confirms that many patients considered to be in clinical remission according the DAS and the ACR/EULAR definitions still have residual synovitis on US. The prognostic significance of US synovitis and the exact place of US in patients reaching clinical remission need to be further evaluated.

Is a Revision a Revision? An Analysis of National Arthroplasty Registries' Definitions of Revision.

BACKGROUND The reported survival of implants depends on the definition used for the endpoint, usually revision. When screening through registry reports from different countries, it appears that revision is defined quite differently. QUESTIONS/PURPOSES The purposes of this study were to compare the definitions of revision among registry reports and to apply common clinical scenarios to these definitions. METHODS We downloaded or requested reports of all available national joint registries. Of the 23 registries we identified, 13 had published reports that were available in English and were beyond the pilot phase. We searched these registries' reports for the definitions of the endpoint, mostly revision. We then applied the following scenarios to the definition of revision and analyzed if those scenarios were regarded as a revision: (A) wound revision without any addition or removal of implant components (such as hematoma evacuation); (B) exchange of head and/or liner (like for infection); (C) isolated secondary patella resurfacing; and (D) secondary patella resurfacing with a routine liner exchange. RESULTS All registries looked separately at the characteristic of primary implantation without a revision and 11 of 13 registers reported on the characteristics of revisions. Regarding the definition of revision, there were considerable differences across the reports. In 11 of 13 reports, the primary outcome was revision of the implant. In one registry the primary endpoint was "reintervention/revision" while another registry reported separately on "failure" and "reoperations". In three registries, the definition of the outcome was not provided, however in one report a results list gave an indication for the definition of the outcome. Wound revision without any addition or removal of implant components (scenario A) was considered a revision in three of nine reports that provided a clear definition on this question, whereas two others did not provide enough information to allow this determination. Exchange of the head and/or liner (like for infection; scenario B) was considered a revision in 11 of 11; isolated secondary patella resurfacing (scenario C) in six of eight; and secondary patella resurfacing with routine liner exchange (scenario D) was considered a revision in nine of nine reports. CONCLUSIONS Revision, which is the most common main endpoint used by arthroplasty registries, is not universally defined. This implies that some reoperations that are considered a revision in one registry are not considered a revision in another registry. Therefore, comparisons of implant performance using data from different registries have to be performed with caution. We suggest that registries work to harmonize their definitions of revision to help facilitate comparisons of results across the world's arthroplasty registries.

Definitions and outcome measures for mucous membrane pemphigoid: recommendations of an international panel of experts

Mucous membrane pemphigoid encompasses a group of autoimmune bullous diseases with a similar phenotype characterized by subepithelial blisters, erosions, and scarring of mucous membranes, skin, or both. Although knowledge about autoimmune bullous disease is increasing, there is often a lack of clear definitions of disease, outcome measures, and therapeutic end points. With clearer definitions and outcome measures, it is possible to directly compare the results and data from various studies using meta-analyses. This consensus statement provides accurate and reproducible definitions for disease extent, activity, outcome measures, end points, and therapeutic response for mucous membrane pemphigoid and proposes a disease extent score, the Mucous Membrane Pemphigoid Disease Area Index.

Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS).

Minimal invasive extracorporeal circulation (MiECC) systems have initiated important efforts within science and technology to further improve the biocompatibility of cardiopulmonary bypass components to minimize the adverse effects and improve end-organ protection. The Minimal invasive Extra-Corporeal Technologies international Society was founded to create an international forum for the exchange of ideas on clinical application and research of minimal invasive extracorporeal circulation technology. The present work is a consensus document developed to standardize the terminology and the definition of minimal invasive extracorporeal circulation technology as well as to provide recommendations for the clinical practice. The goal of this manuscript is to promote the use of MiECC systems into clinical practice as a multidisciplinary strategy involving cardiac surgeons, anaesthesiologists and perfusionists.

The influence of different fever definitions on the rate of fever in neutropenia diagnosed in children with cancer

BACKGROUND The temperature limit defining fever (TLDF) is based on scarce evidence. This study aimed to determine the rate of fever in neutropenia (FN) episodes additionally diagnosed by lower versus standard TLDF. METHODS In a single center using a high TLDF (39.0°C tympanic temperature, LimitStandard), pediatric patients treated with chemotherapy for cancer were observed prospectively. Results of all temperature measurements and CBCs were recorded. The application of lower TLDFs (LimitLow; range, 37.5°C to 38.9°C) versus LimitStandard was simulated in silicon, resulting in three types of FN: simultaneous FN, diagnosed at both limits within 1 hour; earlier FN, diagnosed >1hour earlier at LimitLow; and additional FN, not diagnosed at LimitStandard. RESULTS In 39 patients, 8896 temperature measurements and 1873 CBCs were recorded during 289 months of chemotherapy. Virtually applying LimitStandard resulted in 34 FN diagnoses. The predefined relevantly (≥15%) increased FN rate was reached at LimitLow 38.4°C, with total 44 FN, 23 simultaneous, 11 earlier, and 10 additional (Poisson rate ratioAdditional/Standard, 0.29; 95% lower confidence bound, 0.16). Virtually applying 37.5°C as LimitLow led to earlier FN diagnosis (median, 4.5 hours; 95% CI, 1.0 to 20.8), and to 53 additional FN diagnosed. In 51 (96%) of them, spontaneous defervescence without specific therapy was observed in reality. CONCLUSION Lower TLDFs led to many additional FN diagnoses, implying overtreatment because spontaneous defervescence was observed in the vast majority. Lower TLDFs led as well to relevantly earlier diagnosis in a minority of FN episodes. The question if the high TLDF is not only efficacious but as well safe remains open.

Core outcomes and definitions for pediatric fever and neutropenia research: a consensus statement from an international panel.

BACKGROUND There are no specific recommendations for the design and reporting of studies of children with fever and neutropenia (FN). As a result, there is marked heterogeneity in the variables and outcomes that are reported and new definitions continue to emerge. These inconsistencies hinder the ability of researchers and clinicians to compare, contrast and combine results. The objective was to achieve expert consensus on a core set of variables and outcomes that should be measured and reported, as a minimum, in pediatric FN studies. PROCEDURE The Delphi method was used to achieve consensus among an international group of clinicians, pharmacists, researchers, and patient representatives. Four surveys focusing on (i) the identification of a core set of variables and outcomes; and (ii) definitions of these variables and outcomes, were administered electronically. Consensus was predefined as more than 80% agreement on any statement. RESULTS There were forty-five survey participants and the response rate ranged between 84 and 96%. There was consensus on eight core variables and 10 core outcomes that should be collected and reported in all studies of children with FN. Consensus definitions were identified for all of the core outcomes. CONCLUSION Using the Delphi method, expert consensus on a set of core variables and outcomes, and their corresponding definitions, was achieved. These core sets represent the minimum that should be collected and reported in all studies of children with FN. This will promote collaboration and ensure consistency and comparability between studies.

Comparison of different lattice definitions of the topological charge

We present a comparison of different definitions of the topological charge on the lattice, using a small-volume ensemble with 2 flavours of dynamical twisted mass fermions. The investigated definitions are: index of the overlap Dirac operator, spectral projectors, spectral flow of the HermitianWilson- Dirac operator and field theoretic with different kinds of smoothing of gauge fields (HYP and APE smearings, gradient flow, cooling). We also show some results on the topological susceptibility.

A Proof-Theoretic Analysis of Theories for Stratified Inductive Definitions

In this article we study subsystems SIDᵥ of the theory ID₁ in which fixed point induction is restricted to properly stratified formulas.

Inland Wetland Definitions

This work is the result of a year-long study of the definitions of inland wetlands in which definitions from geology, hydrogeology, hydrology, pedology, biology, systems ecology, sociology, economics, political sciences, public health and law were considered. Of these, geology, hydrogeology, hydrology, biology, systems ecology and economics are discussed in detail in this report and used in writing a final theoretical (ideal) definition of inland wetlands for the glaciated northeastern United States. A proposed legal definition for Connecticut is also offered with descriptions and explanations of terms.