Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer.

BACKGROUND: To improve the efficacy of first-line therapy for advanced non-small cell lung cancer (NSCLC), additional maintenance chemotherapy may be given after initial induction chemotherapy in patients who did not progress during the initial treatment, rather than waiting for disease progression to administer second-line treatment. Maintenance therapy may consist of an agent that either was or was not present in the induction regimen. The antifolate pemetrexed is efficacious in combination with cisplatin for first-line treatment of advanced NSCLC and has shown efficacy as a maintenance agent in studies in which it was not included in the induction regimen. We designed a phase III study to determine if pemetrexed maintenance therapy improves progression-free survival (PFS) and overall survival (OS) after cisplatin/pemetrexed induction therapy in patients with advanced nonsquamous NSCLC. Furthermore, since evidence suggests expression levels of thymidylate synthase, the primary target of pemetrexed, may be associated with responsiveness to pemetrexed, translational research will address whether thymidylate synthase expression correlates with efficacy outcomes of pemetrexed. METHODS/DESIGN: Approximately 900 patients will receive four cycles of induction chemotherapy consisting of pemetrexed (500 mg/m2) and cisplatin (75 mg/m2) on day 1 of a 21-day cycle. Patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 who have not progressed during induction therapy will randomly receive (in a 2:1 ratio) one of two double-blind maintenance regimens: pemetrexed (500 mg/m2 on day 1 of a 21-day cycle) plus best supportive care (BSC) or placebo plus BSC. The primary objective is to compare PFS between treatment arms. Secondary objectives include a fully powered analysis of OS, objective tumor response rate, patient-reported outcomes, resource utilization, and toxicity. Tumor specimens for translational research will be obtained from consenting patients before induction treatment, with a second biopsy performed in eligible patients following the induction phase. DISCUSSION: Although using a drug as maintenance therapy that was not used in the induction regimen exposes patients to an agent with a different mechanism of action, evidence suggests that continued use of an agent present in the induction regimen as maintenance therapy enables the identification of patients most likely to benefit from maintenance treatment.

Impactia: automating the study of the scientific production

Introduction The Andalusian Public Health System Virtual Library (Biblioteca Virtual del Sistema Sanitario Público de Andalucía, BV-SSPA) was set up in June 2006. It consists of a regional government action with the aim of democratizing the health professional access to quality scientific information, regardless of the professional workplace. Andalusia is a region with more than 8 million inhabitants, with 100,000 health professionals for 41 hospitals, 1,500 primary healthcare centres, and 28 centres for non-medical attention purposes (research, management, and educational centres). Objectives The Department of Development, Research and Investigation (R+D+i) of the Andalusian Regional Government has, among its duties, the task of evaluating the hospitals and centres of the Andalusian Public Health System (SSPA) in order to distribute its funding. Among the criteria used is the evaluation of the scientific output, which is measured using bibliometry. It is well-known that the bibliometry has a series of limitations and problems that should be taken into account, especially when it is used for non-information sciences, such us career, funding, etc. A few years ago, the bibliometric reports were done separately in each centre, but without using preset and well-defined criteria, elements which are basic when we need to compare the results of the reports. It was possible to find some hospitals which were including Meeting Abstracts in their figures, while others do not, and the same was happening with Erratum and many other differences. Therefore, the main problem that the Department of R+D+i had to deal with, when they were evaluating the health system, was that bibliometric data was not accurate and reports were not comparable. With the aim of having an unified criteria for the whole system, the Department of R+D+i ordered the BV-SSPA to do the year analysis of the scientific output of the system, using some well defined criteria and indicators, among whichstands out the Impact Factor. Materials and Methods As the Impact Factor is the bibliometric indicator that the virtual library is asked to consider, it is necessary to use the database Web of Science (WoS), since it is its owner and editor. The WoS includes the databases Science Citation Index (SCI), Social Sciences Citation Index (SSCI) and Arts & Humanities Citation Index. To gather all the documents, SCI and SSCI are used; to obtain the Impact Factor and quartils, it is used the Journal Citation Reports, JCR. Unlike other bibliographic databases, such us MEDLINE, the bibliometric database WoS includes the address of all the authors. In order to retrieve all the scientific output of the SSPA, we have done general searches, which are afterwards processed by a tool developed by our library. We have done nine different searches using the field ‘address’; eight of them including ‘Spain’ and each one of the eight Andalusian Regions, and the other one combining ‘Spain’ with all those cities where there are health centres, since we have detected that there are some authors that do not use the region in their signatures. These are some of the search strategies: AD=Malaga and AD=Spain AD=Sevill* and AD=Spain AD=SPAIN AND (AD=GUADIX OR AD=BAZA OR AD=MOTRIL) Further more, the field ‘year’ is used to determine the period. To exploit the data, the BV-SSPA has developed a tool called Impactia. It is a web application which uses a database to store the information of the documents generated by the SSPA. Impactia allows the user to automatically process the retrieved documents, assigning them to their correspondent centres. In order to do the classification of documents automaticaly, it was necessary to detect the huge variability of names of the centres that the authors use in their signatures. Therefore, Impactia knows that if an author signs as “Hospital Universitario Virgen Macarena”, “HVM” or “Hosp. Virgin Macarena”, he belongs to the same centre. The figure attached shows the variability found for the Empresa Publica Hospital de Poniente. Besides the documents from WoS, Impactia includes the documents indexed in Scopus and in other databases, where we do bibliographic searches using similar strategies to the later ones. Aware that in the health centres and hospitals there is a lot of grey literature that is not gathered in databases, Impactia allows the centres to feed the application with these documents, so that all the SSPA scientific output is gathered and organised in a centralized place. The ones responsible of localizing this gray literature are the librarians of each one of the centres. They can also do statements to the documents and indicators that are collected and calculated by Impactia. The bulk upload of documents from WoS and Scopus into Impactia is monthly done. One of the main issues that we found during the development of Impactia was the need of dealing with duplicated documents obtained from different sources. Taking into account that sometimes titles might be written differently, with slashes, comas, and so on, Impactia detects the duplicates using the field ‘DOI’ if it is available or comparing the fields: page start, page end and ISSN. Therefore it is possible to guarantee the absence of duplicates. Results The data gathered in Impactia becomes available to the administrative teams and hospitals managers, through an easy web page that allows them to know at any moment, and with just one click, the detailed information of the scientific output of their hospitals, including useful graphs such as percentage of document types, journals where their scientists usually publish, annual comparatives, bibliometric indicators and so on. They can also compare the different centres of the SSPA. Impactia allows the user to download the data from the application, so that he can work with this information or include them in their centres’ reports. This application saves the health system many working hours. It was previously done manually by forty one librarians, while now it is done by only one person in the BV-SSPA during two days a month. To sum up, the benefits of Impactia are: It has shown its effectiveness in the automatic classification, treatment and analysis of the data. It has become an essential tool for all managers to evaluate quickly and easily the scientific production of their centers. It optimizes the human resources of the SSPA, saving time and money. It is the reference point for the Department of R+D+i to do the scientific health staff evaluation.

The Andalusian Public Health System Virtual Library. Four years on

The Andalusian Public Health System Virtual Library (Biblioteca Virtual del Sistema Sanitario Público de Andalucía, BV-SSPA) set up in June 2006 was determined by the II Quality Plan 2005-2008. It consists of a regional government action with the aim of democratizing the health professional access to quality scientific information, regardless of the professional workplace. Andalusia is a region with more than 8 million inhabitants, with 92,000 health professionals for 41 hospitals, 1,500 primary healthcare centres, and 10 centres for non-medical attention purposes. • To obtain documentary resources for health professionals. • To help citizens to find health information. • To coordinate the Andalusian Health Documentary centres. • To establish strategic agreements with organizations. • To contribute to the Knowledge Management Development • The BV-SSPA acquires in a centralised way, all of the information resources for the whole system. • It offers services for all professionals: o Document Supply Service o Online Learning o User service • Remote access to these resources and services. • Communication and marketing plan to promote the knowledge and use of the BV-SSPA. Presently the BV-SSPA has reached: • The subscription of 2,431 electronic reviews, 8 data bases and other scientific information resources. • The establishment of the Document Supply Service, which focuses all the article orders from and for the Andalusian Public Health System. • The starting up for the online learning platform. • The introduction of the user service and virtual reference service in beta mode. • The use of appropriate tools, as the meta-researcher and the link resolver, which allow the presentation of resources and services in a tidy, easily findable way, through a Web 2.0 page where the user can take part with his contributions and where his offers and suggestion are gathered. • Access to the resources, for the Andalusian Health Professionals worldwide requiring only an internet connection. Andalusian Health Professionals have access to the greatest Health Science Electronic Resources Collection in Spain. The BV-SSPA has become the undisputed medium for the Health Research and Clinical Healthcare in our region, being consolidated as the Knowledge Manager into the Andalusian Public Health System. In 2010, it faces new projects such as the institutional repository creation, HypatiaSalud; the analysis of our research activity; and the drafting of a normalised licence model for the contracting of electronic resources.

Recommendations of the GARIN group for managing non-critically ill patients with diabetes or stress hyperglycaemia and artificial nutrition.

BACKGROUND & AIMS By means of this update, the GARIN working group aims to define its position regarding the treatment of patients with diabetes or stress hyperglycaemia and artificial nutrition. In this area there are many aspects of uncertainty, especially in non-critically ill patients. METHODS Bibliographical review, and specific questions in advance were discussed and answered at a meeting in the form of conclusions. RESULTS We propose a definition of stress hyperglycaemia. The indications and access routes for artificial nutrition are no different in patients with diabetes/stress hyperglycaemia than in non-diabetics. The objective must be to keep pre-prandial blood glucose levels between 100 and 140 mg/dl and post-prandial levels between 140 and 180 mg/dl. Hyperglycemia can be prevented through systematic monitoring of capillary glycaemias and adequately calculate energy-protein needs. We recommend using enteral formulas designed for patients with diabetes (high monounsaturated fat) to facilitate metabolic control. The best drug treatment for treating hyperglycaemia/diabetes in hospitalised patients is insulin and we make recommendations for adapt the theoretical insulin action to the nutrition infusion regimen. We also addressed recommendations for future investigation. CONCLUSIONS This recommendations about artificial nutrition in patients with diabetes or stress hyperglycaemia can add value to clinical work.