The authors examine the implications of electronic shopping for consumers, retailers, and manufacturers. They assume that near-term technological developments will offer consumers unparalleled opportunities to locate and compare product offerings. They examine these advantages as a function of typical consumer goals and the types of products and services being sought and offer conclusions regarding consumer incentives and disincentives to purchase through interactive home shopping vis-à-vis traditional retail formats. The authors discuss implications for industry structure as they pertain to competition among retailers, competition among manufacturers, and retailer-manufacturer relationships.

Interactive home shopping: Consumer, retailer, and manufacturer incentives to participate in

Purpose To update the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases by surveying international experts regarding previous uncertainties within the 2002 consensus, changes that may be necessary based on practice pattern changes and research findings since that time. Methods and Materials A two-phase survey was used to determine revisions and new additions to the 2002 consensus. A total of 49 experts from the American Society for Radiation Oncology, the European Society for Therapeutic Radiology and Oncology, the Faculty of Radiation Oncology of the Royal Australian and New Zealand College of Radiologists, and the Canadian Association of Radiation Oncology who are directly involved in the care of patients with bone metastases participated in this survey. Results Consensus was established in areas involving response definitions, eligibility criteria for future trials, reirradiation, changes in systemic therapy, radiation techniques, parameters at follow-up, and timing of assessments. Conclusion An outline for trials in bone metastases was updated based on survey and consensus. Investigators leading trials in bone metastases are encouraged to adopt the revised guideline to promote consistent reporting. Areas for future research were identified. It is intended for the consensus to be re-examined in the future on a regular basis.

Update of the International Consensus on Palliative Radiotherapy Endpoints for Future Clinical Trials in Bone Metastases

Postgraduate Students: Vladimír Arnot, Daniel Čapek, Rudolf Čejka, Dao Minh, Tomá Dulík, Martin Hrubý, Radek Kočí, Petr Kotásek, Marek Křejpský, Bohuslav Křena, Vladislav Kubíček, Vladimír Marek, Petr Matouek, Ale Mičín, Jiří Očenáek, Tomá Ondráček, Petr Peňás, Jaroslav Ráb, Richard Růička, Luká Sekanina, Ivan Schwarz, Azedien Sllame, Petr Smolík, Jiří Staroba, Josef Strnadel, Luká Szemla, Pavel Tinovský, Michal Tomů, Milan Urbáek, Michal Vojkůvka, Petr Vurm, Frantiek Zbořil

Department of Computer Science and Engineering

ACADEMIC EMERGENCY MEDICINE 2012; 19:217–227 © 2012 by the Society for Academic Emergency Medicine



Abstract

Objectives:  The objective was to compare case ascertainment, agreement, validity, and missing values for clinical research data obtained, processed, and linked electronically from electronic health records (EHR) compared to “manual” data processing and record abstraction in a cohort of out-of-hospital trauma patients.



Methods:  This was a secondary analysis of two sets of data collected for a prospective, population-based, out-of-hospital trauma cohort evaluated by 10 emergency medical services (EMS) agencies transporting to 16 hospitals, from January 1, 2006, through October 2, 2007. Eighteen clinical, operational, procedural, and outcome variables were collected and processed separately and independently using two parallel data processing strategies by personnel blinded to patients in the other group. The electronic approach included EHR data exports from EMS agencies, reformatting, and probabilistic linkage to outcomes from local trauma registries and state discharge databases. The manual data processing approach included chart matching, data abstraction, and data entry by a trained abstractor. Descriptive statistics, measures of agreement, and validity were used to compare the two approaches to data processing.



Results:  During the 21-month period, 418 patients underwent both data processing methods and formed the primary cohort. Agreement was good to excellent (kappa = 0.76 to 0.97; intraclass correlation coefficient [ICC] = 0.49 to 0.97), with exact agreement in 67% to 99% of cases and a median difference of zero for all continuous and ordinal variables. The proportions of missing out-of-hospital values were similar between the two approaches, although electronic processing generated more missing outcomes (87 of 418, 21%, 95% confidence interval [CI] = 17% to 25%) than the manual approach (11 of 418, 3%, 95% CI = 1% to 5%). Case ascertainment of eligible injured patients was greater using electronic methods (n = 3,008) compared to manual methods (n = 629).



Conclusions:  In this sample of out-of-hospital trauma patients, an all-electronic data processing strategy identified more patients and generated values with good agreement and validity compared to traditional data collection and processing methods.

https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1553-2712.2011.01275.x

Electronic versus manual data processing: evaluating the use of electronic health records in out-of-hospital clinical research

Correspondence: Zhengwu Lu 1111 Weyburn LN#29, San Jose, CA 95129, USA Tel +1 201 233 0738 Fax +1 201 949 4085 email zhengwu.lu@ieee.org Abstract: To maintain a competitive position, the biopharmaceutical industry has been facing the challenge of increasing productivity both internally and externally. As the product of the clinical development process, clinical data are recognized to be the key corporate asset and provide critical evidence of a medicine’s efficacy and safety and of its potential economic value to the market. It is also well recognized that using effective technology-enabled methods to manage clinical data can enhance the speed with which the drug is developed and commercialized, hence enhancing the competitive advantage. The effective use of data-capture tools may ensure that high-quality data are available for early review and rapid decision-making. A well-designed, protocol-driven, standardized, site workflow-oriented and documented database, populated via efficient data feed mechanisms, will ensure regulatory and commercial questions receive rapid responses. When information from a sponsor’s clinical database or data warehouse develops into corporate knowledge, the value of the medicine can be realized. Moreover, regulators, payer groups, patients, activist groups, patient advocacy groups, and employers are becoming more educated consumers of medicine, requiring monetary value and quality, and seeking out up-todate medical information supplied by biopharmaceutical companies. All these developments in the current biopharmaceutical arena demand that clinical data management (CDM) is at the forefront, leading change, influencing direction, and providing objective evidence. Sustaining an integrated database or data repository for initial product registration and subsequent postmarketing uses is a long-term process to maximize return on investment for organizations. CDM should be the owner of driving clinical data-cleaning process in consultation with other stakeholders, such as clinical operations, safety, quality assurance, and sites, and responsible for building a knowledge base to add potential value in assisting further study designs or clinical programs. CDM needs to draw on a broad range of skills such as technical, scientific, project management, information technology (IT), systems engineering, and interpersonal skills to tackle, drive, and provide valued service in managing data within the anticipated e-clinical age. Commitment to regulatory compliance is required in this regulated industry; however, a can-do attitude with strong willingness to change and to seek ways to improve CDM functions and processes proactively are essential to continued success and to ensure quality data-driven productivity.

/pdf/clinical-data-management-current-status-challenges-and-2dkk85rbcm.pdf

Clinical data management: Current status, challenges, and future directions from industry perspectives

Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study

This paper describes a case study of an innovative approach to teaching at an engineering school. The postgraduate course Project Work and Communication in Research and Development (R&D) was developed at the Faculty of Electrical Engineering of the University of Ljubljana, Ljubljana, Slovenia. The main aim of the course was to make the entry of young engineering graduates into the business environment as easy as possible. Currently, engineers are facing more and more interdisciplinarity and project work in their daily assignments. The course was designed to remedy any deficiencies in the multidisciplinary professional skills and knowledge of the graduate-level students, and it covered the topics of innovation management, communication in R&D, project management, and problem solving in teams. An end-of-course survey showed positive feedback from participating students. The empirical data (enrollment ratio of students, session attendance ratio, and average student grade) proves that the course met its goal of honing the professional skills of postgraduate engineering students.

/pdf/implementation-of-a-multidisciplinary-professional-skills-1vmk2g0hoh.pdf

Implementation of a Multidisciplinary Professional Skills Course at an Electrical Engineering School

Numerous laboratory tests are used to determine the appropriateness of new formulations in the development process in the paint and coatings industry. New formulations are most often functionally inadequate, unacceptable for environmental or health reasons, or too expensive. Formulators are obliged to repeat laboratory tests until one of the formulations fulfills the minimum requirements. This is cumbersome, slow, and expensive, and can cause ecological problems, wasting materials on tests that do not produce the desired results. The purpose of this research was to find out if there might be a better way forward to increase efficiency and free up formulators to focus on new products. In this experiment, a new paints and coatings development process was redesigned based on the potential benefits of formulation digitalization. Instead of laboratory testing, a digital platform was used that has been developed and stocked with relevant, up-to-date, and complete, usable data. This study found that, by going digital, developers could vastly reduce non-value-added activities in the development process (by as much as 70%) and significantly shorten the entire process throughput time (by up to 48%). Using digital tools to facilitate the development process appears to be a possible way forward for the paint and coatings industry, saving time, materials, and money and protecting the environment.

/pdf/digitalizing-the-paints-and-coatings-development-process-5fzkrh32qq.pdf

Digitalizing the Paints and Coatings Development Process

An essential characteristic of the new product development process is to develop a new marketable product in the shortest possible time with the lowest reasonable costs. Therefore, the key factor of the process is efficiency. The paints and coatings industry development process contain numerous laboratory tests to determine the appropriateness of new formulation. It is proven that digital transformation can reduce the number of laboratory tests and consequently shorten the throughput time of the development process. This raised the question of whether the faster development process also reduces the process’ cost, or they even increase due to information and communication technology implementation. Therefore, the research’s purpose was to determine whether reducing the number of laboratory tests, based on the implementation of information and communication technology (ICT), affects reducing costs in the paints and coatings development process. The conventional process and the redesigned process of paints and coatings development were used as the basis of the research. The comparative analysis of the costs incurred during the development process was made. The analysis compares the types and amount of incurred costs. The article proves that digital transformation has a significant impact on up to 48% on reducing costs of the paints and coatings development process.

https://www.mdpi.com/2079-6412/10/7/703/pdf

Digital Transformation Reduces Costs of the Paints and Coatings Development Process

The article proves the possibility of reducing the negative environmental impacts that arise in the new coating development by redesigning the process and implementing modern informational technologies. Environmental standards in the coating industry are becoming strained, but at the same time the market requires products that provide better protection. In new product development, the key factor is efficiency as it is important to develop a new product in the shortest possible time with the lowest costs. The development process is carried out with a laboratory testing a large number of formulations relatively early while only a few of them meet technical requirements. They are also often not economically viable or acceptable from an environmental point of view. Using the innovative information solution, process workflow was improved. By obtaining data from cloud databases, the environmental relevance as well as the price acceptability of each formulation can be checked, even before the laboratory tests were carried out. Consequently, only those formulations that were environmentally and cost suitable were tested. In this way, the number of laboratory tests were significantly minimized, and consequently amounts of waste were reduced to a minimum.

http://www.pjoes.com/pdf-117657-51822?filename=Reducing Laboratory Test.pdf

Tomaž Kern

Papers

Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study

Implementation of a Multidisciplinary Professional Skills Course at an Electrical Engineering School

Digitalizing the Paints and Coatings Development Process

Digital Transformation Reduces Costs of the Paints and Coatings Development Process

Reducing Laboratory Test Waste in the CoatingDevelopment Process