No surgical innovation without evaluation: the IDEAL recommendations

Surgery and other invasive therapies are complex interventions, the assessment of which is challenged by factors that depend on operator, team, and setting, such as learning curves, quality variations, and perception of equipoise. We propose recommendations for the assessment of surgery based on a five-stage description of the surgical development process. We also encourage the widespread use of prospective databases and registries. Reports of new techniques should be registered as a professional duty, anonymously if necessary when outcomes are adverse. Case series studies should be replaced by prospective development studies for early technical modifications and by prospective research databases for later pre-trial evaluation. Protocols for these studies should be registered publicly. Statistical process control techniques can be useful in both early and late assessment. Randomised trials should be used whenever possible to investigate efficacy, but adequate pre-trial data are essential to allow power calculations, clarify the definition and indications of the intervention, and develop quality measures. Difficulties in doing randomised clinical trials should be addressed by measures to evaluate learning curves and alleviate equipoise problems. Alternative prospective designs, such as interrupted time series studies, should be used when randomised trials are not feasible. Established procedures should be monitored with prospective databases to analyse outcome variations and to identify late and rare events. Achievement of improved design, conduct, and reporting of surgical research will need concerted action by editors, funders of health care and research, regulatory bodies, and professional societies.

The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paper

The methodology of randomized clinical trials is essential for the critical assessment and registration of therapeutic interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement was developed to alleviate the problems arising from the inadequate reporting of randomized controlled trials. The present article reflects on the items that we believe should be included in the CONSORT checklist in the context of conducting and reporting trials in allergen-specific immunotherapy. Only randomized, blinded (in particular blinding of patients, health care providers, and outcome assessors), placebo-controlled Phase III studies in this article. Our analysis focuses on the definition of patients' inclusion and exclusion criteria, allergen standardization, primary, secondary and exploratory outcomes, reporting of adverse events and analysis.

eLEARNING

eLearning through its flexibility and facility of access is seen as a major enabler of lifelong learning (LLL), as a catalyst of change and a chance for small and medium-sized enterprises (SMEs) to improve their business and to integrate into European market. But so far eLearning in the context of vocational educational training mainly has been adopted by large enterprises, while only little activity can be observed in SMEs. The question arises what the chances and challenges for SMEs are and what are the experience with its usage. In this paper after a presentation of key issues in eLearning chances and challenges of eLearning for SMEs are discussed and experiences are exemplified by three EU-funded eLearning projects. The focus lies on the ongoing project ARIEL - Analysing and Reporting the Implementation of Electronic Learning in Europe – coordinated by the Institut Arbeit und Technik (IAT).

eLEARNING - EINE CHANCE FÜR KLEINE UND MITTLERE UNTERNEHMEN

eLearning wird durch seine Flexibilität und Zugänglichkeit als bedeutendes Instrument für die Implementierung lebenslangen Lernens (LLL) angesehen. Es kann für kleine und mittelgroße Unternehmen (KMU) einen Katalysator des Wandels sein und bietet damit die Chance zur Verbesserung der wirtschaftlichen Leistungsfähigkeit. Darüber hinaus kann eLearning dazu dienen, die Integration von KMU in den europäischen Markt zu fördern. Bis jetzt wird eLearning im Rahmen der beruflichen Aus- und Weiterbildung jedoch nahezu ausschließlich in Großunternehmen genutzt, während es in KMU allenfalls eine marginale Rolle spielt. Im ersten Kapitel dieses Artikels wird auf den Perspektivenwechsel in der beruflichen Aus- und Weiterbildung eingegangen. Im Anschluss daran werden die zentralen Elemente von eLearning vorgestellt (Kap. 2). Die mit eLearning verbundenen Chancen und Herausforderungen für KMU diskutiert (Kap. 3). Abschließend wird auf Erfahrungen mit eLearning in der Praxis am Beispiel von drei EU-finanzierten Projekten eingegangen. Das Hauptaugenmerk liegt dabei auf dem laufenden Projekt ARIEL -Analysing and Reporting the Implementation of Electronic Learning in Europe -, das vom Institut Arbeit und Technik, Gelsenkirchen, (IAT) koordiniert wird.

Molecular beacons with a homo-DNA stem: improving target selectivity

Molecular beacons (MBs) are stem-loop DNA probes used for identifying and reporting the presence and localization of nucleic acid targets in vitro and in vivo via target-dependent dequenching of fluorescence. A drawback of conventional MB design is present in the stem sequence that is necessary to keep the MBs in a closed conformation in the absence of a target, but that can participate in target binding in the open (target-on) conformation, giving rise to the possibility of false-positive results. In order to circumvent these problems, we designed MBs in which the stem was replaced by an orthogonal DNA analog that does not cross-pair with natural nucleic acids. Homo-DNA seemed to be specially suited, as it forms stable adenine-adenine base pairs of the reversed Hoogsteen type, potentially reducing the number of necessary building blocks for stem design to one. We found that MBs in which the stem part was replaced by homo-adenylate residues can easily be synthesized using conventional automated DNA synthesis. As conventional MBs, such hybrid MBs show cooperative hairpin to coil transitions in the absence of a DNA target, indicating stable homo-DNA base pair formation in the closed conformation. Furthermore, our results show that the homo-adenylate stem is excluded from DNA target binding, which leads to a significant increase in target binding selectivity

Factorial designs: an overview with applications to orthodontic clinical trials.

Factorial designs for clinical trials are often encountered in medical, dental, and orthodontic research. Factorial designs assess two or more interventions simultaneously and the main advantage of this design is its efficiency in terms of sample size as more than one intervention may be assessed on the same participants. However, the factorial design is efficient only under the assumption of no interaction (no effect modification) between the treatments under investigation and, therefore, this should be considered at the design stage. Conversely, the factorial study design may also be used for the purpose of detecting an interaction between two interventions if the study is powered accordingly. However, a factorial design powered to detect an interaction has no advantage in terms of the required sample size compared to a multi-arm parallel trial for assessing more than one intervention. It is the purpose of this article to highlight the methodological issues that should be considered when planning, analysing, and reporting the simplest form of this design, which is the 2 × 2 factorial design. An example from the field of orthodontics using two parameters (bracket type and wire type) on maxillary incisor torque loss will be utilized in order to explain the design requirements, the advantages and disadvantages of this design, and its application in orthodontic research.

Improvement of the processes around the radiology workplace : avoidance of time delays

Radiologists have been confronted with multiple new challenges in recent years. While there has been a steady increase in the number of radiological examinations and imaging material per examination, examination protocols have become more complex and highly time-consuming whereas case-based remuneration is on the decline. The identification of inefficient components in examination processes and reporting is therefore essential. Where and why do time delays occur? How can they be avoided? The following article provides a brief overview and is designed to stimulate discussion.

Privacy-preserving genomic testing in the clinic: a model using HIV treatment

PURPOSE The implementation of genomic-based medicine is hindered by unresolved questions regarding data privacy and delivery of interpreted results to health-care practitioners. We used DNA-based prediction of HIV-related outcomes as a model to explore critical issues in clinical genomics. METHODS We genotyped 4,149 markers in HIV-positive individuals. Variants allowed for prediction of 17 traits relevant to HIV medical care, inference of patient ancestry, and imputation of human leukocyte antigen (HLA) types. Genetic data were processed under a privacy-preserving framework using homomorphic encryption, and clinical reports describing potentially actionable results were delivered to health-care providers. RESULTS A total of 230 patients were included in the study. We demonstrated the feasibility of encrypting a large number of genetic markers, inferring patient ancestry, computing monogenic and polygenic trait risks, and reporting results under privacy-preserving conditions. The average execution time of a multimarker test on encrypted data was 865 ms on a standard computer. The proportion of tests returning potentially actionable genetic results ranged from 0 to 54%. CONCLUSIONS The model of implementation presented herein informs on strategies to deliver genomic test results for clinical care. Data encryption to ensure privacy helps to build patient trust, a key requirement on the road to genomic-based medicine.Genet Med advance online publication 14 January 2016Genetics in Medicine (2016); doi:10.1038/gim.2015.167.

Statistical testing against baseline was common in dental research

OBJECTIVES To assess the presence of within-group comparisons with baseline in a subset of leading dental journals and to explore possible associations with a range of study characteristics including journal and study design. STUDY DESIGN AND SETTING Thirty consecutive issues of five leading dental journals were electronically searched. The conduct and reporting of statistical analysis in respect of comparisons against baseline or otherwise along with the manner of interpretation of the results were assessed. Descriptive statistics were obtained, and chi-square test and Fisher's exact were undertaken to test the association between trial characteristics and overall study interpretation. RESULTS A total of 184 studies were included with the highest proportion published in Journal of Endodontics (n = 84, 46%) and most involving a single center (n = 157, 85%). Overall, 43 studies (23%) presented interpretation of their outcomes based solely on comparisons against baseline. Inappropriate use of baseline testing was found to be less likely in interventional studies (P < 0.001). CONCLUSION Use of comparisons with baseline appears to be common among both observational and interventional research studies in dentistry. Enhanced conduct and reporting of statistical tests are required to ensure that inferences from research studies are appropriate and informative.

Lessons for emerging state Children's Health Insurance Premium Assistance programs: Case study of the Massachusetts Masshealth Family Assistance Program (MHFAP)

Providing health insurance coverage for vulnerable populations such as low-income high-risk children with limited access to health care is a challenge for many states. Over the past decade, higher private insurance premiums and unpredictable labor markets have increased the number of uninsured and underinsured children nationwide. Due to recent economic downfalls, many states such as Texas, have expressed interest in using premium assistance programs to increase enrollment of low income children and families in private coverage through employer sponsored health insurance. Massachusetts has been especially successful in reducing the number of uninsured children through the implementation of MassHealth Family Assistance Program (MHFAP), an employer based premium assistance program. The purpose of this study is to identify key implementation factors of a fully established premium assistance program which may provide lessons and facilitate implementation of emerging premium assistance programs. ^ The case study of the fully established MassHealth Family Assistance Program (MHFAP) has illustrated the ability of states to expand their Medicaid and SCHIP programs in order to provide affordable health coverage to uninsured and underinsured low income children and their families. As demonstrated by MHFAP, the success of a premium assistance program depends on four key factors: (1) determination of participant and employer eligibility; (2) determination of employer benefits meeting benchmark equivalency (Medicaid or State Children's Health Insurance Program); (3) the use of appropriate marketing and outreach strategies; and (4) establishment of adequate monitoring and reporting techniques. Successful implementation strategies, revealed by the case study of the Massachusetts MassHealth Family Assistance Program, may be used by emerging premium assistance programs, such as Texas Children's Health Insurance Premium Assistance Program (CHIP-PA) toward establishment of an effective, efficient, and equitable employer sponsored health program.^

Quality assurance plan for a vaccine preventable diseases surveillance program

Public health surveillance programs for vaccine preventable diseases (VPD) need functional quality assurance (QA) in order to operate with high quality activities to prevent preventable communicable diseases from spreading in the community. Having a functional QA plan can assure the performance and quality of a program without putting excessive stress on the resources. A functional QA plan acts as a check on the quality of day-to-day activities performed by the VPD surveillance program while also providing data that would be useful for evaluating the program. This study developed a QA plan that involves collection, collation, analysis and reporting of information based on standardized (predetermined) formats and indicators as an integral part of routine work for the vaccine preventable disease surveillance program at the City of Houston Department of Health and Human Services. The QA plan also provides sampling and analysis plans for assessing various QA indicators, as well as recommendations to the Houston Department of Health and Humans Services for implementation of the QA plan. The QA plan developed for VPD surveillance in the City of Houston is intended to be a low cost system that could serve as a template for QA plans as part of other public health programs not only in the city or the nation, but could be adapted for use anywhere across the globe. Having a QA plan for VPD surveillance in the City of Houston would serve well for the funding agencies like the CDC by assuring that the resources are being expended efficiently, while achieving the real goal of positively impacting the health and lives of the recipient/target population. ^

THE DEVELOPMENT OF COMMUNITY COMPETENCE THROUGH A NEIGHBORHOOD ORGANIZATION (LOS ANGELES, MEXICAN-AMERICAN)

This investigation focused on how people cope with the demands of their environment in a competent manner. It sought to assess the effects of learning competent coping behaviors on self-reported well-being. The study chose a community-evolved, organized effort on the part of a group of neighborhoods to build competence in the Mexican-American community of East Los Angeles. This network was a citizen-action organization called the United Neighborhoods Organization. UNO was selected because it concentrated on developing community leaders by using spiritual beliefs and family values as shared community resources. Neighborhood leaders were encouraged to engage in risk-taking and confrontation maneuvers. They were also taught problem-solving skills and provided with social support.^ A survey instrument was developed to assess sociodemographic characteristics, acculturation history and status, willingness to engage in risk-taking and confrontation and self-perceived general well-being. The study relied on eight months of daily participant-observation of the organization, the East Los Angeles environment and the interaction between the two. At the end of the observation period, a sample of 150 UNO participants were given the survey questionnaire as was a matched group of 150 non-UNO participants who were ELA residents.^ The study sample was mostly women, in their middle age years who had lived in the area from 5 to more than 30 years. Significantly more single persons were found in the UNO group. The sample was almost equally divided into English and Spanish speaking respondents. Acculturatively almost all the sample fell in the Very Mexican and Mostly Mexican types. The survey found a trend of association between participating in UNO and reporting feeling well. A statistically significant association was found among UNO participants between taking risks and reporting feeling well, regardless of a tendency for all the sample to minimize risk. A trend was seen for married UNO participants to report feeling well. Slightly more UNO participants were willing to engage in confrontation and a substantial proportion of the participants who were confronters reported feeling well in comparison to their counterparts. Ethnic pride was positively associated with participation in UNO and showed a trend in the expected direction with reported self-perceived well-being. ^

Assessment of work performed by paired students: a pedagogical experience

“Teamwork” is one of the abilities most valued by employers. In [16] we describe the process of adapting to the ECTS methodologies (for ongoing assessment), a course in computer programming for students in a technical degree (Marine Engineering, UPM) not specifically dedicated to computing. As a further step in this process we have emphasized cooperative learning. For this, the students were paired and the work of each pair was evaluated via surprise tests taken and graded jointly, and constituting a substantial part of the final grade. Here we document this experience, discussing methodological aspects, describing indicators for measuring the impact of these methodologies on the educational experience, and reporting on the students’ opinion of it.

The online case study development for the teaching of building structures reinforcement

The Reinforcement of Building Structures is one of the topics of the Master in Building Innovation Technology (MBIT) of Universidad Politécnica de Madrid (UPM). Since the beginning of the delivery of this master, case studies have been chosen as the teaching methodology. For the 2011-2012 course the online education of this subject was implemented, instead of the classical learning based on attendance. Through ICT’s (Information and Communication Technologies) students are provided with much more and more selective information than through the classical learning. ICT’s can be used for search, enquiries and reporting. Using the online tools has been proved, through the results obtained and based on the surveys made amongst students, to be a successful experience.

Real-time determination of airspace wind speed field based on FDR = Determinación en tiempo real del campo de velocidad del viento basado en registradores de datos de vuelo

El estudio del comportamiento de la atmósfera ha resultado de especial importancia tanto en el programa SESAR como en NextGen, en los que la gestión actual del tránsito aéreo (ATM) está experimentando una profunda transformación hacia nuevos paradigmas tanto en Europa como en los EE.UU., respectivamente, para el guiado y seguimiento de las aeronaves en la realización de rutas más eficientes y con mayor precisión. La incertidumbre es una característica fundamental de los fenómenos meteorológicos que se transfiere a la separación de las aeronaves, las trayectorias de vuelo libres de conflictos y a la planificación de vuelos. En este sentido, el viento es un factor clave en cuanto a la predicción de la futura posición de la aeronave, por lo que tener un conocimiento más profundo y preciso de campo de viento reducirá las incertidumbres del ATC. El objetivo de esta tesis es el desarrollo de una nueva técnica operativa y útil destinada a proporcionar de forma adecuada y directa el campo de viento atmosférico en tiempo real, basada en datos de a bordo de la aeronave, con el fin de mejorar la predicción de las trayectorias de las aeronaves. Para lograr este objetivo se ha realizado el siguiente trabajo. Se han descrito y analizado los diferentes sistemas de la aeronave que proporcionan las variables necesarias para obtener la velocidad del viento, así como de las capacidades que permiten la presentación de esta información para sus aplicaciones en la gestión del tráfico aéreo. Se ha explorado el uso de aeronaves como los sensores de viento en un área terminal para la estimación del viento en tiempo real con el fin de mejorar la predicción de las trayectorias de aeronaves. Se han desarrollado métodos computacionalmente eficientes para estimar las componentes horizontales de la velocidad del viento a partir de las velocidades de las aeronaves (VGS, VCAS/VTAS), la presión y datos de temperatura. Estos datos de viento se han utilizado para estimar el campo de viento en tiempo real utilizando un sistema de procesamiento de datos a través de un método de mínima varianza. Por último, se ha evaluado la exactitud de este procedimiento para que esta información sea útil para el control del tráfico aéreo. La información inicial proviene de una muestra de datos de Registradores de Datos de Vuelo (FDR) de aviones que aterrizaron en el aeropuerto Madrid-Barajas. Se dispuso de datos de ciertas aeronaves durante un periodo de más de tres meses que se emplearon para calcular el vector viento en cada punto del espacio aéreo. Se utilizó un modelo matemático basado en diferentes métodos de interpolación para obtener los vectores de viento en áreas sin datos disponibles. Se han utilizado tres escenarios concretos para validar dos métodos de interpolación: uno de dos dimensiones que trabaja con ambas componentes horizontales de forma independiente, y otro basado en el uso de una variable compleja que relaciona ambas componentes. Esos métodos se han probado en diferentes escenarios con resultados dispares. Esta metodología se ha aplicado en un prototipo de herramienta en MATLAB © para analizar automáticamente los datos de FDR y determinar el campo vectorial del viento que encuentra la aeronave al volar en el espacio aéreo en estudio. Finalmente se han obtenido las condiciones requeridas y la precisión de los resultados para este modelo. El método desarrollado podría utilizar los datos de los aviones comerciales como inputs utilizando los datos actualmente disponibles y la capacidad computacional, para proporcionárselos a los sistemas ATM donde se podría ejecutar el método propuesto. Estas velocidades del viento calculadas, o bien la velocidad respecto al suelo y la velocidad verdadera, se podrían difundir, por ejemplo, a través del sistema de direccionamiento e informe para comunicaciones de aeronaves (ACARS), mensajes de ADS-B o Modo S. Esta nueva fuente ayudaría a actualizar la información del viento suministrada en los productos aeronáuticos meteorológicos (PAM), informes meteorológicos de aeródromos (AIRMET), e información meteorológica significativa (SIGMET). ABSTRACT The study of the atmosphere behaviour is been of particular importance both in SESAR and NextGen programs, where the current air traffic management (ATM) system is undergoing a profound transformation to the new paradigms both in Europe and the USA, respectively, to guide and track aircraft more precisely on more efficient routes. Uncertainty is a fundamental characteristic of weather phenomena which is transferred to separation assurance, flight path de-confliction and flight planning applications. In this respect, the wind is a key factor regarding the prediction of the future position of the aircraft, so that having a deeper and accurate knowledge of wind field will reduce ATC uncertainties. The purpose of this thesis is to develop a new and operationally useful technique intended to provide adequate and direct real-time atmospheric winds fields based on on-board aircraft data, in order to improve aircraft trajectory prediction. In order to achieve this objective the following work has been accomplished. The different sources in the aircraft systems that provide the variables needed to derivate the wind velocity have been described and analysed, as well as the capabilities which allow presenting this information for air traffic management applications. The use of aircraft as wind sensors in a terminal area for real-time wind estimation in order to improve aircraft trajectory prediction has been explored. Computationally efficient methods have been developed to estimate horizontal wind components from aircraft velocities (VGS, VCAS/VTAS), pressure, and temperature data. These wind data were utilized to estimate a real-time wind field using a data processing approach through a minimum variance method. Finally, the accuracy of this procedure has been evaluated for this information to be useful to air traffic control. The initial information comes from a Flight Data Recorder (FDR) sample of aircraft landing in Madrid-Barajas Airport. Data available for more than three months were exploited in order to derive the wind vector field in each point of the airspace. Mathematical model based on different interpolation methods were used in order to obtain wind vectors in void areas. Three particular scenarios were employed to test two interpolation methods: a two-dimensional one that works with both horizontal components in an independent way, and also a complex variable formulation that links both components. Those methods were tested using various scenarios with dissimilar results. This methodology has been implemented in a prototype tool in MATLAB © in order to automatically analyse FDR and determine the wind vector field that aircraft encounter when flying in the studied airspace. Required conditions and accuracy of the results were derived for this model. The method developed could be fed by commercial aircraft utilizing their currently available data sources and computational capabilities, and providing them to ATM system where the proposed method could be run. Computed wind velocities, or ground and true airspeeds, would then be broadcasted, for example, via the Aircraft Communication Addressing and Reporting System (ACARS), ADS-B out messages, or Mode S. This new source would help updating the wind information furnished in meteorological aeronautical products (PAM), meteorological aerodrome reports (AIRMET), and significant meteorological information (SIGMET).