Defining publication bias: protocol for a systematic review of highly cited articles and proposal for a new framework.

BACKGROUND: Selective publication of studies, which is commonly called publication bias, is widely recognized. Over the years a new nomenclature for other types of bias related to non-publication or distortion related to the dissemination of research findings has been developed. However, several of these different biases are often still summarized by the term 'publication bias'. METHODS/DESIGN: As part of the OPEN Project (To Overcome failure to Publish nEgative fiNdings) we will conduct a systematic review with the following objectives:- To systematically review highly cited articles that focus on non-publication of studies and to present the various definitions of biases related to the dissemination of research findings contained in the articles identified.- To develop and discuss a new framework on nomenclature of various aspects of distortion in the dissemination process that leads to public availability of research findings in an international group of experts in the context of the OPEN Project.We will systematically search Web of Knowledge for highly cited articles that provide a definition of biases related to the dissemination of research findings. A specifically designed data extraction form will be developed and pilot-tested. Working in teams of two, we will independently extract relevant information from each eligible article.For the development of a new framework we will construct an initial table listing different levels and different hazards en route to making research findings public. An international group of experts will iteratively review the table and reflect on its content until no new insights emerge and consensus has been reached. DISCUSSION: Results are expected to be publicly available in mid-2013. This systematic review together with the results of other systematic reviews of the OPEN project will serve as a basis for the development of future policies and guidelines regarding the assessment and prevention of publication bias.

Des cheminements sur la voie royale : une analyse sociologique des parcours de vie des normaliens-ne-s de Saint-Cloud, Fontenay-aux-Roses et Lyon (1981-1987)

Cette thèse est consacrée à l'analyse des parcours de vie d'un groupe d'anciens et anciennes élèves d'un établissement scolaire d'élite français (les Ecoles normales supérieures de Fontenay-aux-roses, Saint-Cloud et Lyon - promotions 1981-1987). A partir d'une approche longitudinale, son but est de montrer comment l'articulation entre la socialisation familiale, scolaire, professionnelle et conjugale participe à l'orientation progressive des parcours de vie des normalien-ne-s. Elle vise ainsi à remettre en question l'idée, largement répandue, selon laquelle l'intégration d'un cursus scolaire aussi sélectif et prestigieux que celui des ENS garantirait à Lou.te.s les élèves les mêmes chances d'accès aux positions dominantes de l'espace social. Alliant l'analyse de trois types de données (archives, questionnaires, entretiens), cette thèse met en évidence la manière dont inégalités relatives à l'origine sociale et au sexe se recomposent, une fois les portes de l'institution franchies. Elle montre que, dans un contexte socio-historique marqué par une forte expansion scolaire, il est plus que jamais nécessaire d'opérer une articulation systématique entre l'analyse des conditions sociales de réussite scolaire et l'analyse des conditions sociales d'exploitation des titres scolaires, afin de rendre compte des processus complexes de reproduction des inégalités et d'esquisser certaines de leur conditions de dépassement. Abstract: This thesis is dedicated to the life course analysis of alumni from one of the most prestigious French Grandes écoles (the Ecoles Normales Supérieures of Fontenay-aux- roses, Saint-Cloud and Lyon - classes of 1981.-1987). Through a longitudinal perspective, it aims to analyze how family, educational, professional and conjugal socialization processes combine to shape the life course of this particular group of graduates. The main goal of this research is to question the widespread belief that the French Grandes Ecoles guarantee automatic access to the very top of the professional and social hierarchy for all of their graduates. Based on a mixed methods research design (archive data, a questionnaire survey and semi-structured interviews), this thesis shows that, according to social origin and gender, ENS graduates actually adopt a diverse range of professional careers. It show how, in a socio-historical context characterized by a general increase in educational levels, any analysis of social inequalities should combine two levels of analysis: the social conditions of access to educational credentials, on the one hand, and the labor market value of formal qualifications, on the other hand. Our results suggest that the combined analysis of these two processes provide useful insight into the increasingly complex processes of social reproduction - and suggest fruitful perspectives for reducing some sources of inequality.

Designing online interaction to address disciplinary competencies: A cross-country comparison of faculty perspectives

This study was conducted at colleges in three countries (United States, Venezuela, and Spain) and across three academic disciplines (engineering, education, and business), to examine how experienced faculty define competencies for their discipline, and design instructional interaction for online courses. A qualitative research design employing in-depth interviews was selected. Results show that disciplinary knowledge takes precedence when faculty members select competencies to be developed in online courses for their respective professions. In all three disciplines, the design of interaction to correspond with disciplinary competencies was often influenced by contextual factors that modify faculty intention. Therefore, instructional design will vary across countries in the same discipline to address the local context, such as the needs and expectations of the learners, faculty perspectives, beliefs and values, and the needs of the institution, the community, and country. The three disciplines from the three countries agreed on the importance of the following competencies: knowledge of the field, higher order cognitive processes such as critical thinking, analysis, problem solving, transfer of knowledge, oral and written communication skills, team work, decision making, leadership and management skills, indicating far more similarities in competencies than differences between the three different applied disciplines. We found a lack of correspondence between faculty¿s intent to develop collaborative learning skills and the actual development of them. Contextual factors such as faculty prior experience in design, student reluctance to engage in collaborative learning, and institutional assessment systems that focus on individual performance were some of these reasons.

Is blood still thicker than water? A life-course perspective on the transformation of family and friends' roles in personal networks

This thesis addresses the issue of the moving boundaries between family and friends' roles in personal networks, adopting a life-course perspective and using Switzerland as a case study. In a period of major changes in personal life happening in contemporary Western societies, understanding the organization of personal networks intertwined with the unfolding of individual life courses is of prime importance in facing new challenges with regard to social integration. The data stem from a representative national survey carried out in 2011 named Family tiMes, including 803 individuals born either in 1950-1955 or in 1970-1975. An innovative research design was adopted, combing cross-sectional ego-centered network data and retrospective longitudinal life-course data. The results show continuing boundaries between family and friends' roles and that family keeps a prominent role in personal networks despite the notable importance of friendship ties. One relationship stands out above all, that with the partner, followed quite a few steps behind by those with children. Regarding life courses, de-standardization tendencies were found in family formation and also a persistent gendering of occupational trajectories. Two kinds of life trajectories are particularly intertwined with personal networks, co-residence and partnership trajectories, both related to the unfolding of family life. In particular, transition to parenthood functions as a turning point in individuals' lives, deeply transforming their sociability. Finally, a twofold pluralization process was identified, affecting simultaneously the organization of personal networks and the unfolding of individual life courses. This thesis contributes to the literature on the sociology of family and personal life, and to fruitful interlinkage between the network approach and the life-course perspective.

Anàlisi del recurs pilot "cases d'infants: nou paradigma d'atenció i tractament a la infància i l'adolescència".

El treball que es presenta a continuació és una recerca aplicada, consistent en l’anàlisi descriptiva d’una mostra d’infants i adolescents de 5 a 19 anys atesos al projecte “Cases d’Infants” des del desembre de 2010 fins al juliol de 2013. Aquesta investigació pretén donar a conèixer la nova perspectiva o paradigma d’atenció a la infància i l’adolescència a Catalunya que neix de la Llei dels Drets i les Oportunitats de la Infància i l’Adolescència (LDOIA, maig de 2010): basada en la prevenció, el model sistèmic i de complexitat, la col·laboració de la família com a element de canvi, el treball en xarxa i interprofessionalitat, la participació dels infants i adolescents, i la territorialitat, principalment. Un cop feta aquesta aproximació teòrica, s’ha concretat identificant aquesta nova perspectiva al projecte pilot “Cases d’Infants” (nascut al setembre de 2010), el qual desplega les actuacions que sorgeixen d’aquesta filosofia de treball i suport. Per a elaborar aquesta recerca s’ha emprat un disseny d’investigació no experimental descriptiu, on s’han associat i comparat variables per tal d’identificar interferències en les relacions –a través de proves estadístiques-, i proposar una certa tendència i pronòstic de les característiques del perfil atès al projecte i les interferències d’algunes variables amb el recurs final de l’infant o adolescent. Finalment, s’extreuen unes conclusions en relació a la bibliografia inicial i els resultats obtinguts en l’anàlisi de la mostra estudiada.

Implementing evidence-based patient and family education on oral anticoagulation therapy: a community-based participatory project.

AIMS AND OBJECTIVES: This study aimed at developing and implementing evidence-based patient and family education on oral anticoagulation therapy. BACKGROUND: The number of persons with chronic diseases who live at home is increasing. They have to manage multiple diseases and complex treatments. One such treatment is oral anticoagulation therapy, a high risk variable dose medication. Adherence to oral anticoagulation therapy is jeopardised by limited information about the medications, their risk and complications, the impact of individual daily routine and the limited inclusion of family members in education. Hence, improved and tailored education is essential for patients and families to manage oral anticoagulation therapy at home. DESIGN AND METHODS: A community-based participatory research design combined with the Precede-Proceed model was used including a systematic literature review, posteducation analysis, an online nurse survey, a documentation analysis and patient/family interviews. The study was conducted between April 2010-December 2012 at a department of general internal medicine in a teaching hospital in Switzerland. Participants were the department's nursing and medical professionals including the patients and their families. RESULTS: The evidence-based patient and family education on oral anticoagulation therapy emerged comprising a learning assessment, teaching units, clarification of responsibilities of nurse professionals and documentation guidelines. CONCLUSION AND CLINICAL RELEVANCE: The inclusion of the whole department has contributed to the development and implementation of this evidence-based patient family education on oral anticoagulation therapy, which encompasses local characteristics and patient preferences. This education is now being used throughout the department.

Re-examination of Customer Satisfaction Measurement Results

Asiakastyytyväisyys on läheisesti yhteydessä yrityksen taloudelliseen menestykseen ja yrityksen yleisen laadun määrittämiseen. Asiakastyytyväisyyden mittaamista vaaditaan tällä hetkellä myös ISO 9001 laatujärjestelmästandardissa. Tämän vuoksi tarve tutkia ja mitata asiakastyytyväisyyttä on kasvanut yritysten ja yhteisöjen joukossa. Kokonaisvaltainen asiakastyytyväisyyden tutkiminen sisältää sekä asiakastyytyväisyyden mittaamista ja järjestelmällistä asiakaspalautteen tutkimista ja analysointia. Asiakastyytyväisyysmittaamisessa käytetään menettelytapoja ja tekniikoita, jotka ovat yleisesti käytössä markkinointitutkimuksessa. Menetelmiä on kuitenkin mukautettava, jotta ne sopivat asiakastyytyväisyyden mittaamiseksi. Asiakastyytyväisyysmittaustulosten perusanalyysit ovat helppo toteuttaa mutta tulokset voidaan helposti tulkita väärin ilman syvällisempiä tilastomatemaattisia analyysejä. Asiakastyytyväisyyden mittaaminen on helppo toteuttaa mutta tutkimussuunnitelma ja tulostenkeräysmenetelmä pitää suunnitella huolellisesti, jotta mittaustulosten luotettavuus ja validiteetti voidaan taata. Jotta asiakastyytyväisyyden tutkimisesta saataisiin maksimaalinen hyöty, pitäisi tutkimuksen myös tarkastella kuinka asiakastyytyväisyys, yrityksen sisäinen ja ulkoinen laatu sekä asiakaslojaalisuus ovat yhteydessä toisiinsa.

STRATEGIC-1: A multiple-lines, randomized, open-label GERCOR phase III study in patients with unresectable wild-type RAS metastatic colorectal cancer.

BACKGROUND: The management of unresectable metastatic colorectal cancer (mCRC) is a comprehensive treatment strategy involving several lines of therapy, maintenance, salvage surgery, and treatment-free intervals. Besides chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan), molecular-targeted agents such as anti-angiogenic agents (bevacizumab, aflibercept, regorafenib) and anti-epidermal growth factor receptor agents (cetuximab, panitumumab) have become available. Ultimately, given the increasing cost of new active compounds, new strategy trials are needed to define the optimal use and the best sequencing of these agents. Such new clinical trials require alternative endpoints that can capture the effect of several treatment lines and be measured earlier than overall survival to help shorten the duration and reduce the size and cost of trials. METHODS/DESIGN: STRATEGIC-1 is an international, open-label, randomized, multicenter phase III trial designed to determine an optimally personalized treatment sequence of the available treatment modalities in patients with unresectable RAS wild-type mCRC. Two standard treatment strategies are compared: first-line FOLFIRI-cetuximab, followed by oxaliplatin-based second-line chemotherapy with bevacizumab (Arm A) vs. first-line OPTIMOX-bevacizumab, followed by irinotecan-based second-line chemotherapy with bevacizumab, and by an anti-epidermal growth factor receptor monoclonal antibody with or without irinotecan as third-line treatment (Arm B). The primary endpoint is duration of disease control. A total of 500 patients will be randomized in a 1:1 ratio to one of the two treatment strategies. DISCUSSION: The STRATEGIC-1 trial is designed to give global information on the therapeutic sequences in patients with unresectable RAS wild-type mCRC that in turn is likely to have a significant impact on the management of this patient population. The trial is open for inclusion since August 2013. TRIAL REGISTRATION: STRATEGIC-1 is registered at Clinicaltrials.gov: NCT01910610, 23 July, 2013. STRATEGIC-1 is registered at EudraCT-No.: 2013-001928-19, 25 April, 2013.

Clinical Development Strategies and Outcomes in First-in-Human Trials of Monoclonal Antibodies.

PURPOSE: We conducted a comprehensive review of the design, implementation, and outcome of first-in-human (FIH) trials of monoclonal antibodies (mAbs) to clearly determine early clinical development strategies for this class of compounds. METHODS: We performed a PubMed search using appropriate terms to identify reports of FIH trials of mAbs published in peer-reviewed journals between January 2000 and April 2013. RESULTS: A total of 82 publications describing FIH trials were selected for analysis. Only 27 articles (33%) reported the criteria used for selecting the starting dose (SD). Dose escalation was performed using rule-based methods in 66 trials (80%). The median number of planned dose levels was five (range, two to 13). The median of the ratio between the highest planned dose and the SD was 27 (range, two to 3,333). Although in 56 studies (68%) at least one grade 3 or 4 toxicity event was reported, no dose-limiting toxicity was observed in 47 trials (57%). The highest planned dose was reached in all trials, but the maximum-tolerated dose (MTD) was defined in only 13 studies (16%). The median of the ratio between MTD and SD was eight (range, four to 1,000). The recommended phase II dose was indicated in 34 studies (41%), but in 25 (73%) of these trials, this dose was chosen without considering toxicity as the main selection criterion. CONCLUSION: This literature review highlights the broad design heterogeneity of FIH trials testing mAbs. Because of the limited observed toxicity, the MTD was infrequently reached, and therefore, the recommended phase II dose for subsequent clinical trials was only tentatively defined.

The Effect of Cigarette Smoking on Diabetic Peripheral Neuropathy: A Systematic Review and Meta-Analysis.

OBJECTIVE: Studies suggest that smoking may be a risk factor for the development of microvascular complications such as diabetic peripheral neuropathy (DPN). The objective of this study was to assess the relationship between smoking and DPN in persons with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS: A systematic review of the PubMed, Embase, and Cochrane clinical trials databases was conducted for the period from January 1966 to November 2014 for cohort, cross-sectional and case-control studies that assessed the relationship between smoking and DPN. Separate meta-analyses for prospective cohort studies and case-control or cross-sectional studies were performed using random effects models. RESULTS: Thirty-eight studies (10 prospective cohort and 28 cross-sectional) were included. The prospective cohort studies included 5558 participants without DPN at baseline. During follow-up ranging from 2 to 10 years, 1550 cases of DPN occurred. The pooled unadjusted odds ratio (OR) of developing DPN associated with smoking was 1.26 (95% CI 0.86-1.85; I(2) = 74%; evidence grade: low strength). Stratified analyses of the prospective studies revealed that studies of higher quality and with better levels of adjustment and longer follow-up showed a significant positive association between smoking and DPN, with less heterogeneity. The cross-sectional studies included 27,594 participants. The pooled OR of DPN associated with smoking was 1.42 (95% CI 1.21-1.65; I(2) = 65%; evidence grade: low strength). There was no evidence of publication bias. CONCLUSIONS: Smoking may be associated with an increased risk of DPN in persons with diabetes. Further studies are needed to test whether this association is causal and whether smoking cessation reduces the risk of DPN in adults with diabetes.

Aasian toinen todellisuus - Suomen suurlähetystöjen monikulttuurisen johtamisen haasteet

Monikulttuurinen johtaminen on globalisaation ja nopean kansainvälistymisen takia erittäin ajankohtainen aihe. Suomessa sitä on kuitenkin tutkittu vasta vähän. Tämän tutkimuksen tarkoituksena on tutkia Suomen suurlähetystöjenmonikulttuurista johtamista Aasian eri kohdemaissa ja kulttuureissa sekä ottaa osaa tieteelliseen keskusteluun monikulttuurisesta johtamisesta. Tutkimuksen kohdemaiksi on valittu neljä Aasian maata, jotka ovat tällä hetkellä hyvin ajankohtaisia nopean talouskasvunsa takia. Itä-Aasiasta mukana ovat Etelä-Korea (Korean tasavalta), Japani ja Kiinan kansantasavalta sekä Kaakkois-Aasiasta tutkimuksessa mukana on Malesia. Tämä tutkimus on laadullinen tutkimus, jonka aineisto koostuu kahdesta laadulliselle tutkimukselle poikkeuksellisesta avoimesta kyselystä, jotka on lähetetty edellä mainittujen maiden suurlähettiläille eri kohdemaihin. Analyysissä menetelmänä on käytetty teemoittelua, jonka avulla on voitu jäsentää saatua aineistoa. Näin teemojen vertailu on myös ollut helpompaa. Tutkimuksen tuloksista kävi ilmi, että monikulttuurinen johtaminen on erittäin haasteellista kansallisten kulttuurien eroista johtuen. Arvot ovat hyvin keskeisessä osassa kulttuuria tutkittaessa ja niiden erot voivat vaikeuttaa kanssakäymistä eri kulttuureista tulevien ihmisten kesken, koska asioiden merkitykset jäävät usein arvoituksiksi vieraasta kulttuurista tuleville henkilöille. Kansallisen kulttuurin tekijöistä kieli, arvot ja uskonto ovat merkittäviä monikulttuurisen johtamisen kannalta. Tutkimuksesta kävi myös ilmi, että Itä- Aasian maissa konfutselaisuudella on suuri merkitys yhteiskuntafilosofiana. Se on muokannut yhteiskunnan arvoja, tapoja ja rakenteita. Vanhempien ja ylempiarvoisten ihmisten arvostus ja vahvasti hierarkkinen yhteiskuntarakenne ovat tyypillisiä konfutselaisuuden piirteitä. Kulttuurin ulottuvuuksista merkityksellisempiä tämän tutkimuksen kannalta ovat yksilöllisyys vs. kollektiivisuus, valtaetäisyys ja konfutselaisuuden dynamiikka (lyhyen vs. pitkän aikavälin suuntautuminen). Kaikki tämän tutkimuksen maat ovat kollektiivisia sekä niissä valtaetäisyys on myös korkea. Tämä tuo haasteita monikulttuuriseen johtamiseen Suomen suurlähetystöissä, koska suomalainen kulttuuri on useimpien länsimaiden tapaan yksilöllinen ja valtaetäisyys on suhteellisen matala. Konfutselaisuuden dynamiikka vaikuttaa lähinnä vain Itä-Aasian maissa tuoden mukanaan erittäin vahvan hierarkian, jota ei voi sivuuttaa. Tutkimuksen aineistoa käsitellään näytenäkökulmasta, eikä sitä ei voisuoraan verrata muihin organisaatioihin tai kulttuureihin. Toisaalta jokaisen kansallisen kulttuurin ihmiset toimivat tietyllä tavalla tietyssä kontekstissa, riippumatta siitä, missä organisaatiossa he työskentelevät. Kulttuuri ohjaa ihmisen toimintaa ja kansallinen kulttuuri on yrityskulttuuria voimakkaampi tekijä.

Use of fine-needle aspirate calcitonin to detect medullary thyroid carcinoma: A systematic review.

BACKGROUND: The measurement of calcitonin in washout fluids of thyroid nodule aspirate (FNA-calcitonin) has been reported as accurate to detect medullary thyroid carcinoma (MTC). The results from these studies have been promising and the most updated version of ATA guidelines quoted for the first time that "FNA findings that are inconclusive or suggestive of MTC should have calcitonin measured in the FNA washout fluid." Here we aimed to systematically review published data on this topic to provide more robust estimates. RESEARCH DESIGN AND METHODS: A comprehensive computer literature search of the medical databases was conducted by searching for the terms "calcitonin" AND "washout." The search was updated until April 2015. RESULTS: Twelve relevant studies, published between 2007 and 2014, were found. Overall, 413 thyroid nodules or neck lymph nodes underwent FNA-calcitonin, 95 were MTC lesions and 93 (97.9%) of these were correctly detected by this measurement regardless of their cytologic report. CONCLUSIONS: The present study shows that the above ATA recommendation is well supported. Almost all MTC lesions are correctly detected by FNA-calcitonin and this technique should be used to avoid false negative or inconclusive results from cytology. The routine determination of serum calcitonin in patients undergoing FNA should improve the selection of patients at risk for MTC, guiding the use of FNA-calcitonin in the same FNA sample and providing useful information to the cytopathologist for the morphological assessment and the application of tailored ancillary tests.

The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.

Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.

Aprendizaje cooperativo y apoyo a la mejora de las prácticas inclusivas

El objetivo de este artículo es presentar una investigación sobre el desarrollo del Programa Cooperar para Aprender /Aprender a Cooperar a través de un proceso de formación-asesoramiento, diseñado por el Grup de recerca Atenció a la diversitat (GRAD) de la Universidad de Vic. Presentamos los objetivos, centrados en el aprendizaje cooperativo y la inclusión del alumnado que encuentra más barreras para el aprendizaje y la participación en las aulas ordinarias. Describimos el diseño de investigación y los instrumentos para identificar los cambios en las representaciones del profesorado, la evaluación de los aprendizajes realizados con estructuras cooperativas, la cohesión del grupo clase y la evolución de los procesos de inclusión desde las fases de introducción hasta la consolidación del aprendizaje cooperativo, en los seis centros escolares en que se realiza la investigación. Finalizamos presentando algunos resultados iniciales de la investigación.