AbstractBackground. The 7th Framework Programme for Research and Technological Development is helping the European Union to prepare for an integrative system for intelligent management of biodiversity knowledge. The infrastructure that is envisaged and that will be further developed within the Programme “Horizon 2020” aims to provide open and free access to taxonomic information to anyone with a requirement for biodiversity data, without the need for individual consent of other persons or institutions. Open and free access to information will foster the re-use and improve the quality of data, will accelerate research, and will promote new types of research. Progress towards the goal of free and open access to content is hampered by numerous technical, economic, sociological, legal, and other factors. The present article addresses barriers to the open exchange of biodiversity knowledge that arise from European laws, in particular European legislation on copyright and database protection rights.We present a legal point of view as to what will be needed to bring distributed information together and facilitate its re-use by data mining, integration into semantic knowledge systems, and similar techniques. We address exceptions and limitations of copyright or database protection within Europe, and we point to the importance of data use agreements. We illustrate how exceptions and limitations have been transformed into national legislations within some European states to create inconsistencies that impede access to biodiversity information.Conclusions. The legal situation within the EU is unsatisfactory because there are inconsistencies among states that hamper the deployment of an open biodiversity knowledge management system. Scientists within the EU who work with copyright protected works or with protected databases have to be aware of regulations that vary from country to country. This is a major stumbling block to international collaboration and is an impediment to the open exchange of biodiversity knowledge. Such differences should be removed by unifying exceptions and limitations for research purposes in a binding, Europe-wide regulation.PageBreak Biodiversity data and information are important sources of knowledge for many biological, geological, and environmental research disciplines as well as for the development of policies relating to the natural environment and the management of natural resources . The corScientific names of organisms are an important component of biodiversity information. They act as a tally of how much biodiversity has been described. They are universally used to index biodiversity information . Other sThe infrastructure for a system that will intelligently manage and integrate digital biodiversity information - an Open Biodiversity Knowledge Management System (OBKMS) - will need access to all names, taxonomic information, and other biodiversity data in formats that can be understood by both humans and computers . If we ath Framework Programme for Research and Technological Development, and in the perspective of the EU Framework Programme for Research and Innovation “Horizon 2020”, has evaluated the requirements for an OBKMS that will: (i) offer a robust service-oriented architecture suited to working with taxon-level information distributed at multiple PageBreaksources; (ii) have a central registry of sources and services to help users find available data and services and to understand how to use them; (iii) provide open and free access to all names and taxonomic information for anyone with a requirement for biodiversity data, without depending on consent of other individuals or institutions; and (iv) facilitate the re-use of biodiversity data and information  and right holder(s) of such contributions grant(s) to all users a free, irrevocable, worldwide, right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship (…), as well as the right to make small numbers of printed copies for their personal use.2. A complete version of the work and all supplemental materials, including a copy of the permission as stated above, in an appropriate standard electronic format is deposited (and thus published) in at least one online repository using suitable technical standards (…) that is supported and maintained by an academic institution, scholarly society, government agency, or other well-established organisation that seeks to enable open access, unrestricted distribution, interoperability, and long-term archiving” .In the “Joint Declaration on Open Science for the 21st Century”, presented by the European Federation of Academies of Sciences and Humanities and the European Commission on 11th April, 2012, the vision of Open Science is summarised as follows:“Open Science envisages optimal sharing of research results and tools: publications, data, software, and educational resources. It will rely on advanced e-infrastructures that enable online research collaboration. The potential to link cognate, and to re-use initially unrelated datasets will reveal unexpected relationships and will trigger new dynamics of scientific discovery. The collective intelligence of scientific communities will be unleashed through new collaborations across institutional, disciplinary, sectoral and national boundaries. The open science environment will help restore transparency and integrity to the scientific enterprise, for all to see. New points of exchange with non-academic end-users of scientific knowledge will be created, and progress will be made towards the vision of scientifically literate societies: this may require releasing scientific data in forms that are accessible to citizens” .In order to reach that goal, scientific publications must be made openly available, as soon after publication and as freely as possible. Restrictions should be based on specific justifications, such as to protect security, endangered species, or to protect the privacy of individuals. As a first step, the principles of open science should be applied to all content arising from – fully or partially – publicly funded research. Research proposals requesting public funds should include measures aimed at advancing open science and apply open access principles. Further steps will be necessary in order to extend these principles to all scientific research of general societal interest. A discussion, however, of how to balance commercial interests with societal interests is beyond the topic of the present contribution.PageBreakCopyright protects works that are original, individual, new creations with respect of their form of presentation. It gives the owner the exclusive right to reproduce the work, to distribute it, to communicate it to the public, to make derivative versions, to transfer rights to others as well as several other rights . CopyrigScientific names of species follow a standardised format that was developed more than 250 years ago. This includes the latinisation of words and the use of a binomial name for species. Even when a name is new, the form of expression follows the well-established pattern. The same can be said about taxonomic treatments and much other taxonomic information which is expressed in standardised forms and language. The familiar nature of the information is valuable as it helps other scientists to understand the treatments, to compare them, and to draw their content together in their own scientific work. The familiar nature means that the material cannot be subject to copyright. Elements of taxonomic information that are ‘familiar’ to taxonomists were summarised as a ‘blue list’ that included: scientific names; etymology of names, authorities for names, nomenclatural information and opinions, rank and/or hierarchical organisation or classification; alphabetical, chronological, phylogenetic, palaeontological, geographical, ecological, host-based, or feature-based ordering of taxa; synonyms and taxonomic opinions; references to relevant literature, type material, and images; data about materials examined; information on overall distribution, ecology, conservation and uses and descriptions of the taxon .None-the-less, copyright statements are often associated with taxonomic information - especially on web sites. These refer to ownership and address the re-use of content. Most of these statements lack legal foundation because the data and information to which they refer do not qualify as works in the sense of copyright legislation. There are no legitimate copyright restrictions on the re-use of such information. A non-copyrightable publication remains non-copyrightable even if the author or others choose to mark it with a copyright statement, a copyright mark (such as ©), or with a Creative Commons license.Biodiversity data and information are rarely presented as unembellished flat lists. They are parts of websites, articles, monographs, and other forms of publications. Even if the data or information are not copyrightable, the website or monograph as a whole may qualify as work and therefore be copyright protected. If the process of re-use requires the reproduction of copyright protected parts of the source, then authorisation of the copyright holder is required .European copyright legislation is well aware of the fact that copyright may present a barrier to scientific work. The EU-Directive 2001/29/EC on the harmonisation of certain aspects of copyright and related rights in the information society (Article 5.2.Member States may provide for exceptions and limitations to the reproduction right provided for in Article 2 in the following cases:(…)c) in respect of specific acts of reproduction made by publicly accessible libraries, educational establishments or museums, or by archives, which are not for direct or indirect economic or commercial advantage.(…)”Article 5.3Member States may provide for exceptions and limitations to the rights provided for in Article 2 and 3 in the following cases:a) use for the sole purpose of illustration for teaching or scientific research, as long as the source, including the author’s name, is indicated, unless this turns out to be impossible and to the extent justified by the non-commercial purposes to be achieved;(…)n) use by communication or making available, for the purpose of research or private study, to individual members of the public by dedicated terminals on the premises of establishments referred to in paragraph 2(c) of works and other subject-matter no subject to purchase or licensing terms which are contained in their collections;(…)”PageBreakKnowledge Economy”, the EU Commission makes it clear that this situation is a major stumbling block to international scientific cooperation within the EU and declares that “limiting teaching and research to a specific location is considered to be contrary to the realities of modern life”  of the Directive 96/9/EC, member states may stipulate that lawful users of a database may extract or re-utilise a substantial part of its contents for the purposes of scientific research. This exception is only applicable if transformed into national law by individual member states of the EU. Therefore, scientists in different EU member states have to be aware of different legal frameworks as far as database legislation is concerned.Access to and re-use of biodiversity data and information is not only regulated by copyright and database protection, but also through individual data use agreements (DUA). Such agreements can relate to data and information irrespective of whether copyright or databases rights apply. They can have the form of a written contact, or be a general “terms of use”-statement which the user has to accept before accessing protected data and information. Indeed, a DUA may simply be said to have been agreed as a result of accessing content. Such agreements are frequently called “licenses” although the term is, in many cases, inappropriate from a legal point of view.A DUA is only valid if both parties have accepted the conditions of access or terms of use, and applies only to those parties. In many cases, it may be difficult to decide if there is an agreement or not and if a potential licensee has accepted it. An agreement requires an active expression of intent, whether spoken, written, or in fact. The mere action of accessing data and information on a website that is accompanied by a “terms of use”-statement or any similar declaration, will rarely be considered as consent.Creative Commons licenses or similar are a form of data use agreement. They are declared unilaterally by a “licensor”, and they are valid under the condition that the licensee has accepted them. Their importance lies in the fact that they often declare a restriction to copyright and, with the new version 4, to database protection: The licensor declares to any interested user that he or she will not claim copyright or database rights as long as the material is re-used in a way that is explicitly authorised by the CC-license. Such terms of use appeal to licensors and licensees as it increases access to and use of works and databases.PageBreakIn Europe, data use agreements can regulate the access to and the re-use of copyrighted works or protected databases only when there is no binding legal regulation in form of exceptions and limitations to copyright or database protection. The European Court of Justice ruled in a judgment of June 23, 2013, as follows: “Where a Member State has decided, pursuant to a provision in Article 5(2) and (3) of Directive 2001/29, to exclude, from the material scope of that provision, any right for the rightholders to authorise reproduction of their protected works or other subject-matter, any authorising act the rightholders may adopt is devoid of legal effects under the law of that State” . BindingExceptions and limitations to copyright and database protection apply if transformed into national law of member states of the European Union or the European Economic Area. The resulting national legislation differs from country to country . The folCopyright and database protection in Denmark is provided for by the “LBK nr 202 af 27/02/2010 Gældende (Ophavsretsloven)” . The excPageBreak§ 13 (referring to article 5.3.a of Directive 2001/29/EC):Til brug i undervisningsvirksomhed kan der fremstilles eksemplarer af udgivne værker samt ved optagelse foretages eksemplarfremstilling af værker, som udsendes i radio eller fjernsyn, såfremt betingelserne for aftalelicens efter § 50 er opfyldt. (…)§ 14 :Offentlige eller private institutioner, organisationer og erhvervsvirksomheder kan til intern brug i deres virksomhed ved fotokopierung eller lignende fremstille eller lade fremstille eksemplarer af fagmæssige artikler i aviser, tidsskrifter og samleværker, af korte afsnit af andre udgivne værker af fagmæssig art, af musikværker samt af illustrationer, som er gengivet i tilslutning til teksten, såfremt betingelserne for aftalelicens efter § 50 er opfyldt. Sådanne eksemplarer må kun udnyttes inden for virksomhed, som omfattes af den i § 50 forudsatte aftale. (…)§ 16 (referring to article 5.2.c of Directive 2001/29/EC):1Offentlige arkiver, offentlige biblioteker og andre biblioteker, der helt eller delvis finanseres af det offentlige, samt statslige museer og museer, der er godkendt efter museumsloven, må gengive og sprede eksemplarer af værker til brug i deres virksomhed i overensstemmelse med bestemmelserne i stk. 2-6, såfremt det ikke sker i erhvervsøjemed. Dette gælder dog ikke for edb-programmer i digital form bortset fra computerspil.2Institutionerne må fremstille eksemplarer i sikkerheds- og beskyttelsesøjemed.3Såfremt et eksemplar i en institutions samling er ufuldstændigt, må institutionen fremstille eksemplarer af de manglende dele, medmindre værket kan erhverves i almindelig handel eller hos udgiveren.4Biblioteker kan fremstille eksemplarer af udgivne værker, der bør være tilgængelige i bibliotekets samlinger, men som ikke kan erhverves i almindelig handel eller hos udgiveren. (…)§ 16a (referring to article 5.3.n of Directive 2001/29/EC):Offentliggjorte værker kan gøres tilgængelige for enkeltpersoner på de i § 16, stk. 1, nævnte institutioner til personligt gennemsyn eller studium på stedet ved hjælp af teknisk udstyr. (…)§ 16b (referring to article 5.2.c and 5.3.n of Directive 2001/29/EC):Offentlige biblioteker og andre biblioteker, der helt eller delvis finansieres af det offentlige, kan på bestilling i digital form gengive artikler fra aviser, tidskrifter og samleværker, kortere afsnit af bøger og andre udgivne litterære værker samt illustrationer og noder, som er gengivet i tilslutning til teksten, såfremt betingelserne for aftalelicens efter § 50 er opfyldt. Bestemmelsen i 1. pkt. omfatter ikke udsendelse i radio eller fjernsyn eller tilrådighedsstillelse af værker på en sådan måde, at almenheden får adgang til dem på et individuelt valgt sted og tidspunkt (…).PageBreak§ 50 (referring to extended collective licenses):1Aftalelicens efter §§ 13, 14 og § 16 b, § 17, stk. 4, og §§ 24, 30, 30 a og 35 kan påberåbes af brugere, der har indgået en aftale om den pågældende værksudnyttelse med en organisation, som omfatter en væsentlig del of ophavsmændene til en bestemt art af værker, der anvendes i Danmark.2Aftalelicens kan desuden påberåbes af brugere, der inden for et nærmere defineret område har indgået aftale om værksudnyttelse med en organisation, der omfatter en væsentlig del of ophavsmændene til en bestemt art of værker, der anvendes i Danmark på det pågældende område. Dette gælder dog ikke, hvis ophavsmanden over for nogen af de aftalesluttende partner har nedlagt forbud mod værkets udnyttelse.3Aftalelicensen giver brugeren ret til at udnytte andre værker af samme art, selv om ophavsmændene til disse værker ikke repræsenteres af organisationen. Aftalelicensen giver brugeren ret til at benytte de ikke-repræsenterede ophavsmænds værker på den måde og på de vilkår, som følger af den aftale, der er indgået med organisationen.st part of the “Code de la propriété intellectuelle (L. n° 92-597 du 1er juillet 1992)” (Copyright and database protection in France is provided for by the 1t 1992)” . The excArt. L 122-5-8° (referring to article 5.2.c of Directive 2001/29/EC):Lorsque l’oeuvre a été divulguée, l’auteur ne peut interdire:(…)8°La reproduction d’une œuvre et sa représentation effectuées à des fins de conservation ou destinées à préserver les conditions de sa consultation à des fins de recherche ou d’études privées par des particuliers, dans les locaux de l’établissement et sur des terminaux dédiés par des bibliothèques accessibles au public, par des musées ou par des services d’archives, sous réserve que ceux-ci ne recherchent aucun avantage économique ou commercial;(…)Art. L 122-5-3° (referring to paragraph 5.3.a of Directive 2001/29/EC):Lorsque l’oeuvre a été divulguée, l’auteur ne peut interdire:(…)3°Sous réserve que soient indiqués clairement le nom de l’auteur et la source:(…)PageBreakou récréative, dès lors que le public auquel cette représentation ou cette reproduction est destinée est composé majoritairement d’élèves, d’étudiants, d’enseignants ou de chercheurs directement concernées, que l’utilisation de cette représentation ou cette reproduction ne donne lieu à aucune exploitation commerciale (…)e) La représentation ou la reproduction d’extraits d’œuvres, sous réserve des œuvres conçues à des fins pédagogiques, des partitions de musique et des œuvres réalisés pour une édition numérique de l’écrit, à des fins exclusives d’illustration dans le cadre de l’enseignement et de la recherche, à l’exclusion de toute activité ludique Copyright and database protection in Germany is provided for by the “Gesetz über Urheberrecht und verwandte Schutzrechte (Urheberrechtsgesetz – UrhG) vom 9. September 1965“ . The exc§ 52b UrhG (referring to paragraph 5.3.n of Directive 2001/29/EC):Zulässig ist, veröffentlichte Werke aus dem Bestand öffentlich zugänglicher Bibliotheken, Museen oder Archive, die keinen unmittelbar oder mittelbar wirtschaftlichen oder Erwerbszweck verfolgen, ausschliesslich in den Räumen der jeweiligen Einrichtung an eigens dafür eingerichteten elektronischen Leseplätzen zur Forschung und für private Studien zugänglich zu machen, soweit dem keine vertraglichen Regeln entgegenstehen. Es dürfen grundsätzlich nicht mehr Exemplare eines Werkes an den eingerichteten elektronischen Leseplätzen gleichzeitig zugänglich gemacht werden, als der Bestand der Einrichtung umfasst. Für die Zugänglichmachung ist eine angemessene Vergütung zu zahlen. (…)§ 52a UrhG (referring to paragraph 5.3.a of Directive 2001/29/EC):(1) Zulässig ist,1. veröffentlichte kleine Teile eines Werkes, Werke geringen Umfangs sowie einzelne Beiträge aus Zeitungen oder Zeitschriften zur Veranschaulichung im Unterricht an Schulen, Hochschulen, nichtgewerblichen Einrichtungen der Aus- und Weiterbildung sowie an Einrichtungen der Berufsbildung ausschliesslich für den bestimmt abgegrenzten Kreis von Unterrichtsteilnehmern oder2. veröffentlichte Teile eines Werkes, Werke geringen Umfangs sowie einzelne Beiträge aus Zeitungen oder Zeitschriften ausschliesslich für einen bestimmt abgegrenzten Kreis von Personen für deren eigene wissenschaftliche Forschungöffentlich zugänglich zu machen, soweit dies zu dem jeweiligen Zweck geboten und zur Verfolgung nicht kommerzieller Zwecke gerechtfertigt ist.(2) Die öffentliche Zugänglichmachung eines für den Unterrichtsgebrauch an Schulen bestimmten Werkes ist stets nur mit Einwilligung des Berechtigten zulässig. Die öffentliche Zugänglichmachung eines Filmwerkes ist vor Ablauf von zwei Jahren nach Beginn der üblichen regulären Auswertung in Filmtheatern im Geltungsbereich dieses Gesetzes stets nur mit Einwilligung des Berechtigten zulässig.(…)PageBreak§53 UrhG (referring to paragraph 5.3.a of Directive 2001/29/EC):(1) Zulässig sind einzelne Vervielfältigungen eines Werkes durch eine natürliche Person zum privaten Gebrauch auf beliebigen Trägern, sofern sie weder unmittelbar noch mitttelbar Erwerbszwecken dienen, soweit nicht zur Vervielfältigung eine offensichtlich rechtswidrig hergestellte oder öffentlich zugänglich gemachte Vorlage verwendet wird. Der zur Vervielfältigung Befugte darf die Vervielfältigungsstücke auch durch einen anderen herstellen lassen, sofern dies unentgeltlich geschieht oder es sich um Vervielfältigungen auf Papier oder einem andern ähnlichen Träger mittels beliebiger photomechanischer Verfahren oder anderer Verfahren mit ähnlicher Wirkung handelt.(2) Zulässig ist, einzelne Vervielfältigungsstücke eines Werkes herzustellen oder herstellen zu lassen1. zum eigenen wissenschaftlichen Gebrauch, wenn und soweit die Vervielfältigung zu diesem Zweck geboten ist und sie keinen gewerblichen Zwecken dient,2. (…)(3) Zulässig ist, Vervielfältigungsstücke von kleinen Teilen eines Werkes, von Werken von geringem Umfang oder von einzelnen Beiträgen, die in Zeitungen oder Zeitschriften erschienen und öffentlich zugänglich gemacht worden sind, zum eigenen Gebrauch1. zur Veranschaulichung des Unterrichts in Schulen, in nichtgewerblichen Einrichtungen der Aus- und Weiterbildung sowie in Einrichtungen der Berufsbildung in der für die Unterrichtsteilnehmer erforderlichen Anzahl oder2. für staatliche Prüfungen und Prüfungen in Schulen, Hochschulen, in nichtgewerblichen Einrichtungen der Aus- und Weiterbildung sowie in der Berufsbildung in der erforderlichen Anzahlherzustellen oder herstellen zu lassen, wenn und soweit die Vervielfältigung zu diesem Zweck geboten ist. Die Vervielfältigung eines Werkes, das für den Unterrichtsgebrauch bestimmt ist, ist stets nur mit Einwilligung des Berechtigten zulässig.(…)§53a (referring to paragraph 5.3.n of Directive 2001/29/EC):(1) Zulässig ist auf Einzelbestellung die Vervielfältigung und Übermittlung einzelner in Zeitungen und Zeitschriften erschienener Beträge sowie kleiner Teile eines erschienenen Werkes im Wege des Post- oder Faxversands durch öffentliche Bibliotheken, sofern die Nutzung durch den Besteller nach § 53 zulässig ist. Die Vervielfältigung und Übermittlung in sonstiger elektronischer Form ist ausschliesslich als grafische Datei und zur Veranschaulichung des Unterrichts oder für Zwecke der wissenschaftlichen Forschung zulässig, soweit dies zur Verfolgung nicht gewerblicher Zwecke gerechtfertigt ist. Die Vervielfältigung und Übermittlung in sonstiger elektronischer Form ist ferner nur dann zulässig, wenn der Zugang zu den Beiträgen oder kleinen Teilen eines Werkes den Mitgliedern der Öffentlichkeit nicht offensichtlich von Orten und Zeiten ihrer Wahl mittels einer vertraglichen Vereinbarung zu angemessenen Bedingungen ermöglicht wird.(…)PageBreak§87c (referring to art. 9(b) of Directive 96/9/EC):(1) Die Vervielfältigung eines nach Art oder Umfang wesentlichen Teils einer Datenbank ist zulässig1. (…)2. zum eigenen wissenschaftlichen Gebrauch, wenn und soweit die Vervielfältigung zu diesem Zweck geboten ist und der wissenschaftliche Gebrauch nicht zu gewerblichen Zwecken erfolgt,3. für die Benutzung zur Veranschaulichung des Unterrichts, sofern sie nicht zu gewerblichen Zwecken erfolgt.In den Fällen der Nummern 2 und 3 ist die Quelle deutlich anzugeben.(…)Copyright and database protection in Italy is provided for by Art. 2575 ss. of the Codice Civile and in the “Legge 22 Aprile 1941 n. 633 Protezione del diritto d’autore e di altri diritti connessi al suo esercizio“ . The excArt. 68 (referring to article 5.2.c of the Directive 2001/29/EC):1. E’ libera la riproduzione di singole opere o brani di opere per uso personale dei lettori, fatta a mano o con mezzi di riproduzione non idonei a spaccio o diffusione dell’opera nel pubblico.2. E’ libera la fotocopia di opere esistenti nelle biblioteche accessibili al pubblico o in quelle scolastiche, nei musei pubblici o negli archivi pubblici, effettuata dai predetti organismi per i propri servizi, senza alcun vantaggio economico o commerciale diretto o indiretto.3. Fermo restando il divieto di riproduzione di spartiti e partiture musicali, è consentita, nei limiti del quindici per cento di ciascun volume o fascicolo di periodico, escluse le pagine di pubblicità, la riproduzione per uso personale di opere dell’ingegno effettuata mediante fotocopia, xerocopia o sistema analogo.4. I responsabili dei punti o centri di riproduzione, i quali utilizzino nel proprio ambito o mettano a disposizione di terzi, anche gratuitamente, apparecchi per fotocopia, xerocopia o analogo sistema di riproduzione, devono corrispondere un compenso agli autori ed agli editori delle opere dell’ingegno pubblicate per le stampe che, mediante tali apparecchi, vengono riprodotte per gli usi previsti nel comma 3. La misura di detto compenso e le modalità per la riscossione e la ripartizione sono determinate secondo i criteri posti all’art. 181- ter della presente legge. Salvo diverso accordo tra la SIAE e le associazione delle categorie interessate, tale compenso non può essere inferiore per ciascuna pagina riprodotta al prezzo medio a pagina rilevato annualmente dall’ISTAT per i libri.PageBreakArt. 70 (referring to article 5.3.a of the Directive 2001/29/EC):1. Il riassunto, la citazione o la riproduzione di brani o di parti di opera e la loro comunicazione al pubblico sono liberi se effettuati per uso di critica o di discussione, nei limiti giustificati da tali fini e purché non costituiscano concorrenza all’utilizzazione economica dell’opera; se effettuati a fini di insegnamento o di ricerca scientifica l’utilizzo deve inoltre avvenire per finalità illustrative e per fini non commerciali.1-bis. È consentita la libera pubblicazione attraverso la rete internet, a titolo gratuito, di immagini e musiche a bassa risoluzione o degradate, per uso didattico o scientifico e solo nel caso in cui tale utilizzo non sia a scopo di lucro. Con decreto del Ministro per i beni e le attività culturali, sentiti il Ministro della pubblica istruzione e il Ministro dell’università e della ricerca, previo parere delle Commissioni parlamentari competenti, sono definiti i limiti all’uso didattico o scientifico di cui al presente comma.2. Nelle antologie ad uso scolastico la riproduzione non può superare la misura determinata dal regolamento, il quale fissa la modalità per la determinazione dell’equo compenso.3. Il riassunto, la citazione o la riproduzione debbono essere sempre accompagnati dalla menzione del titolo dell’opera, dei nomi dell’autore, dell’editore e, se si tratti di traduzione, del traduttore, qualora tali indicazioni figurino sull’opera riprodotta.Art. 71-ter (referring to article 5.3.n of the Directive 2001/29/EC):1. E’ libera la comunicazione o la messa a disposizione destinata a singoli individui, a scopo di ricerca o di attività privata di studio, su terminali aventi tale unica funzione situati nei locali delle biblioteche accessibili al pubblico, degli istituti di istruzione, nei musei e negli archivi, limitatamente alle opere o ad altri materiali contenuti nelle loro collezioni e non soggetti a vincoli derivanti da atti di cessione o da licenza.Art. 64-sexies (referring to article 9(b) of Directive 96/9/EC):1. Non sono soggetti all’autorizzazione di cui all’articolo 64-quinquies da parte del titolare del diritto:a) l’accesso o la consultazione della banca di dati quando abbiano esclusivamente finalità didattiche o di ricerca scientifica, non svolta nell’ambito di un’impresa, purché si indichi la fonte e nei limiti di quanto giustificato dallo scopo non commerciale perseguito. Nell’ambito di tali attività di accesso e consultazione, le eventuali operazioni di riproduzione permanente della totalità o di parte sostanziale del contenuto su altro supporto sono comunque soggette all’autorizzazione del titolare del diritto;b) l’impiego di una banca di dati per fini di sicurezza pubblica o per effetto di una procedura amministrativa o giurisdizionale.2. Non sono soggette all’autorizzazione dell’autore le attività indicate nell’articolo 64-quinquies poste in essere da parte dell’utente legittimo della banca di dati o di una sua copia, se tali attività sono necessarie per l’accesso al contenuto della stessa banca di dati e per il suo normale impiego; se l’utente legittimo è autorizzato ad utilizzare solo una parte della banca di dati, il presente comma si applica unicamente a tale parte.PageBreak3. Le clausole contrattuali pattuite in violazione del comma 2 sono nulle ai sensi dell’articolo 1418 del codice civile.4. Conformemente alla Convenzione di Berna per la protezione delle opere letterarie e artistiche, ratificata e resa esecutiva con legge 20 giugno 1978, n. 399, le disposizioni di cui ai commi 1 e 2 non possono essere interpretate in modo da consentire che la loro applicazione arrechi indebitamente pregiudizio al titolare del diritto o entri in conflitto con il normale impiego della banca di dati.Art. 102-ter (referring to article 9(b) of Directive 96/9/EC):1. L’utente legittimo della banca di dati messa a disposizione del pubblico non può arrecare pregiudizio al titolare del diritto d’autore o di un altro diritto connesso relativo ad opere o prestazioni contenute in tale banca.2. L’utente legittimo di una banca di dati messa in qualsiasi modo a disposizione del pubblico non può eseguire operazioni che siano in contrasto con la normale gestione della banca di dati o che arrechino un ingiustificato pregiudizio al costitutore della banca di dati.3. Non sono soggette all’autorizzazione del costitutore della banca di dati messa per qualsiasi motivo a disposizione del pubblico le attività di estrazione o reimpiego di parti non sostanziali, valutate in termini qualitativi e quantitativi, del contenuto della banca di dati per qualsivoglia fine effettuate dall’utente legittimo. Se l’utente legittimo è autorizzato ad effettuare l’estrazione o il reimpiego solo di una parte della banca di dati, il presente comma si applica unicamente a tale parte.4. Le clausole contrattuali pattuite in violazione dei commi 1, 2 e 3 sono nulle.Copyright and database protection in Norway is provided for by the “Lov av 12. mai 1961 om opphavsrett til åndverk m.v. (åndverksloven)” . The exc§ 16. (referring to paragraph 5.2.c and 5.3.n of Directive 2001/29/EC):Kongen kan gi regler om rett for arkiv, bibliotek, museer og undervisnings- og forskningsinstitusjoner til å fremstille eksemplar av verk for konserverings- og sikringsformål og andre særskilte formål. Bestemmelsen gjelder ikke for ervervsmessig bruk.Kongen kan gi regler om at arkiv, bibliotek, museer og undervisningsinstitusjoner ved hjelp av terminaler i egne lokaler, kan gjøre verk i samlingene tilgjengelig for enkeltpersoner når det skjer til forskningsformål eller private studieformål.PageBreak.§ 16a. (referring to paragraph 5.2.c and 5.3.n of Directive 2001/29/EC):Arkiv, bibliotek og museer som angitt i § 16 første ledd kan fremstille eksemplar av utgitte verk i samlingene og gjøre slike verk tilgjengelig for allmennheten når betingelsene for avtalelisens etter § 36 første ledd er oppfylt.§ 36. (concerning extended collective licenses)Når det foreligger avtale med organisasjon som nevnt i § 38a som tillater slik bruk av verk som nevnt i §§ 13b, 14, 16a, 17b, 30, 32 og 34, har bruker som omfattes av avtalen, overfor rettighetshaver som ikke er omfattet, rett til på samme område og på samme måte å utnytte verk av samme art som dem avtalen gjelder . Bestemmelsen gjelder bare for bruk som skjer i samsvar med det avtalen fastsetter. Bestemmelsen gjelder ikke i forhold til kringkastingsforetaks rettigheter i sine sendinger.§ 38a. (concerning extended collective licenses)Avtale som skal ha virkning som nevnt i § 36 første ledd, må inngås av organisasjon som på området representerer en vesentlig del av opphavsmennene til verk som brukes i Norge, og som er godkjent av departementet. For bruk på nærmere angitte områder kan Kongen bestemme at den organisasjon som godkjennes, må være en felles organisasjon for de berørte rettighetshavere.Kongen kan gi nærmere bestemmelser om kontroll med organisasjoner og fond som mottar vederlag til videre fordeling.Copyright and database protection in Sweden is provided for by the “Lag (1960:729) om upphovsrätt till litterära och künstnärliga verk“ . The excPageBreak16 § (referring to paragraph 5.2.c of Directive 2001/29/EC):De arkiv och bibliotek som avses i tredje och fjärde styckena har rätt att framställa exemplar av verk, dock inte datorprogram,1. för bevarende-, kompletterings- eller forskningsändamål,2. för att tillgodose lånesökandes önskemål om enskilda artiklar eller korta avsnitt eller om material som av säkerketsskäl inte bör lämnas ut ioriginal, eller3. för användning i läsapparater.(…)Rätt till exemplarframställning och spridning enligt denna paragraf har1. de statliga och kommunala arkivmyndigheterna,2. Statens ljud- och bildarkiv,3. de vetenskapeliga bibliotek och fackbibliotek som drivs av det allmänna samt4. folkbiblioteken.(…)In addition, libraries and certain other institutions may make their collection available to the public on the basis of a so called extended collective licence . An extended collective licence is an agreement between a qualified user (the library) and a national collecting society which represents a considerable number of Swedish right-holders that oversee certain uses of protected works. The agreement applies not only to the use of works of represented authors but also to the use of any other work of the same kind:“En avtalelicens som avses i 42 b–42 f §§ gäller för utnyttjande av verk på visst sätt, när ett avtal har ingåtts om utnyttjande av verk påsådant sätt med en organisation som företräder ett flertal svenska upphovsmän på området. Avtalelicensen ger använderen rätt att utnytta verk av det slag som avses med avtalet trots att verkens upphovsmän inte företräds av organisationen” (42a §).Copyright and database protection in Switzerland is provided for by the “Bundesgesetz über das Urheberrecht und verwandte Schutzrechte  vom 9. Oktober 1992“ . As SwitSwitzerland does not provide for any database protection. Databases are protected only as far as they qualify as works in the sense of copyright. A specific database protection in form of a sui-generis-right does not exist.PageBreakthe private use of copyrighted works. As Swiss law applies, the concept of “private” includes the internal use in private entities and institutions, including commercial organisations and enterprises. Consequently, the exceptions for private use apply to a much wider set of subjects than in other countries. The regulations are to be found in the following articles:Swiss copyright law provides no exceptions and limitations for scientific research. However, it provides exceptions for reproduction of copyrighted works within public libraries, educational institutions, museums and archives as well as exceptions for Art. 19 Verwendung zum Eigengebrauch1Veröffentlichte Werke dürfen zum Eigengebrauch verwendet werden. Als Eigengebrauch gilt:a. jede Werkverwendung im persönlichen Bereich und im Kreis von Personen, die unter sich eng verbunden sind, wie Verwandte und Freunde;b. jede Werkverwendung der Lehrperson in der Klasse;c. das Vervielfältigen von Werkexemplaren in Betrieben, öffentlichen Verwaltungen, Institutionen, Kommissionen und ähnlichen Einrichtungen für die interne Information und Kommunikation.2Wer zum Eigengebrauch berechtigt ist, darf unter Vorbehalt von Absatz 3 die dazu erforderlichen Vervielfältigungen auch durch Dritte herstellen lassen; als Dritte im Sinne dieses Absatzes gelten auch Bibliotheken, andere öffentliche Institutionen und Geschäftsbetriebe, die ihren Benützern und Benützerinnen Kopiergeräte zur Verfügung stellen.3Ausserhalb des privaten Kreises nach Absatz 1 Buchstabe a sind nicht zulässig:a. die vollständige oder weitgehend vollständige Vervielfältigung im Handel erhältlicher Werkexemplare;b. die Vervielfältigung von Werken der bildenden Kunst;c. die Vervielfältigung von graphischen Aufzeichnungen von Werken der Musik;d. die Aufnahme von Vorträgen, Aufführungen oder Vorführungen eines Werkes auf Ton-, Tonbild- oder Datenträger.(…)Art. 24 Archivierungs- und Sicherungsexemplare(…)1bis Öffentlich zugängliche Bibliotheken, Bildungseinrichtungen, Museen und Archive dürfen die zur Sicherung und Erhaltung ihrer Bestände notwendigen Werkexemplare herstellen, sofern mit diesen Kopien kein wirtschaftlicher oder kommerzieller Zweck verfolgt wird.(…)PageBreakRegulations 1997”  and in the “The Copyright and Rights in Databases ns 1997” . The excSection 29 CDPA (referring to article 5.3.a and 5.3.n of Directive 2001/29/EC):(1) Fair dealing with a work for the purposes of research for a non-commercial purpose does not infringe any copyright in the work provided that it is accompanied by a sufficient acknowledgement.(1B) No acknowledgement is required in connection with fair dealing for the purposes mentioned in subsection (1) where this would be impossible for reasons of practicality or otherwise.(1C) Fair dealing with a work for the purposes of private study does not infringe any copyright in the work.(3) Copying by a person other than the researcher or student himself is not fair dealing if—(a) in the case of a librarian, or a person acting on behalf of a librarian, that person does anything which regulations under section 42A (copying by librarians: single copies of published works), or(b) in any other case, the person doing the copying knows or has reason to believe that it will result in copies of substantially the same material being provided to more than one person at substantially the same time and for substantially the same purpose.Section 29A CDPA (referring to article 5.2.c of Directive 2001/29/EC):(1) The making of a copy of a work by a person who has lawful access to the work does not infringe copyright in the work provided that—(a) the copy is made in order that a person who has lawful access to the work may carry out a computational analysis of anything recorded in the work for the sole purpose of research for a non-commercial purpose, and(b) the copy is accompanied by a sufficient acknowledgement .(2) Where a copy of a work has been made under this section, copyright in the work infringed if—(a) the copy is transferred to any other person, except where the transfer is authorised by the copyright owner, or(b) the copy is used for any purpose other than that mentioned in subasection (1)(a), except where the use is authorised by the copyright owner.(3) If a copy made under this section is subsequently dealt with—(a) it is to be treated as an infringing copy for the purposes of that dealing, and(b) if that dealing infringes copyright, it is to be treated as an infringing copy for all subsequent purposes.(4) In subsection (3) “dealt with” means sold or let for hire, or offered or exposed for ale or hire.PageBreak(5) To the extent that a term of a contract purports to prevent or restrict the making of a copy which, by virtue of this section, would not infringe copyright, that term is unenforceable”.Section 38 CDPA (referring to article 5.2.c of Directive 2001/29/EC):(1) The librarian of a prescribed library may, if the prescribed conditions are complied with, make and supply a copy of an article in a periodical without infringing any copyright in the text, in any illustrations accompanying the text or in the typographical arrangement.(2) The prescribed conditions shall include the following—(a) that copies are supplied only to persons satisfying the librarian that they require them for the purposes of—(i) research for a non-commercial purpose, or(ii) private study, and will not use them for any other purpose;(b) that no person is furnished with more than one copy of the same article or with copies of more than one article contained in the same issue of a periodical; and(c) that persons to whom copies are supplied are required to pay for them a sum not less than the cost  attributable to their production.Section 39 CDPA (referring to article 5.2.c of Directive 2001/29/EC):(1) The librarian of a prescribed library may, if the prescribed conditions are complied with, make and supply from a published edition a copy of part of a literary, dramatic or musical work  without infringing any copyright in the work, in any illustrations accompanying the work or in the typographical arrangement.(2) The prescribed conditions shall include the following—(a) that copies are supplied only to persons satisfying the librarian that they require them for the purposes of—(i) research for a non-commercial purpose, or(ii) private study,and will not use them for any other purpose;(b) that no person is furnished with more than one copy of the same material or with a copy of more than a reasonable proportion of any work; and(c) that persons to whom copies are supplied are required to pay for them a sum not less than the cost  attributable to their production.Section 40 CDPA :(1) Regulations for the purposes of sections 38 and 39 (copying by librarian of article or part of published work) shall contain provision to the effect that a copy shall be supplied only to a person satisfying the librarian that his requirement is not related to any similar requirement of another person.PageBreak(2) The regulations may provide—(a) that requirements shall be regarded as similar if the requirements are for copies of substantially the same material at substantially the same time and for substantially the same purpose; and(b) that requirements of persons shall be regarded as related if those persons receive instruction to which the material is relevant at the same time and place.Section 42A CDPA (referring to article 5.3.a und 5.3.n of Dirctive 2001/29 EC):(1) A librarian of a library which is not conducted for profit may, if the conditions in subsection (2) are met, make and supply a single copy of—(a) one article in any one issue of a periodical, or(b) a reasonable proportion of any other published work, without infringing copyright in the work.(2) The conditions are—(a) a copy is supplied in response to a request from a person who has provided the librarian with a declaration in writing which includes the information set out in subsection (3), and(b) the librarian is not aware that the declaration is false in a material particular.(3) The information which must be included in the declaration is—(a) the name of the person who requires the copy and the material which that person requires,(b) s statement that the person has not previously been supplied with a copy of that material by any library,(c) a statement that the person requires the copy for the purpose of research for a non-commercial purpose or private study, will use it only for those purposes and will not supply the copy to any other person, and(d) a statement that to the best of the person’s knowledge, no other person with whom the person works or studies has made, or intends to make, at or about the same time as the person’s request, a request for substantially the same material for substantially the same purpose.Section 50 D CDPA (referring to Article 9(b) of Directive 96/9/EC):(1) It is not an infringement of copyright in a database for a person who has a right to use the database or any part of the database, (whether under a licence to do any of the acts restricted by the copyright in the database or otherwise) to do, in the exercise of that right, anything which is necessary for the purposes of access to and use of the contents of the database or of that part of the database.(2) Where an act which would otherwise infringe copyright in a database is permitted under this section, it is irrelevant whether or not there exists any term or condition in any agreement which purports to prohibit or restrict the act .PageBreakPageBreakThis review illustrates that national provisions in Europe on copyright and database protection regarding exceptions and limitations for research purposes differ not only in certain details but in substance. There is no consistency among national legislations despite Directive 2001/29/EC that aims to achieve harmonisation. In none of the regulations presented here is there a general exception or limitation to the copyright protection for the use of works for research purposes. In some countries, there are exceptions for some particular uses in the sector of scientific research. In Scandinavian countries, there is an exception linked to extended collective licence schemes. In the United Kingdom there is a very detailed exception for research purposes linked to a fair-dealing-clause. Exceptions to the sui-generis-database-protection are even more varied .Most national regulations seem to be oriented to a rather outdated concept of scientific work. Provisions that link copyright exceptions to the premises of certain institutions are incompatible with the current nature of scientific collaboration among institutions. Provisions that allow for the printing of copies but not for the storage on digital devices (as is the case in Germany), or that forbid the sharing of documents (as is the case in the recently introduced section 42A of the British CPDA), impair the efficiency of scientific work and confine researchers to outdated working methods.Regulations that link exceptions and limitations to idiosyncratic definitions of works  make modern research techniques such as automated text generation and data mining difficult. It is not possible to search or analyse automatically a body of documents if there is no general rule about what can and cannot be done with all the documents. In the interests of efficient scientific research, exceptions and limitations of copyright and database protection should, therefore, apply to every object that is of interest to researchers.There is no longer a clear distinction between commercial and non-commercial research . Public-The emergence of an integrated system for the management of biodiversity knowledge will be hampered by current copyright and database protection. This hurdle should be removed by unifying exceptions and limitations for research purposes in a binding, Europe-wide regulation.PageBreak


Investigate the relationship of the tumor volume after preoperative chemotherapy(TVAPQ) and before preoperative chemotherapy (TVBPQ) with overall survival at twoand at five years, and lifetime.  Our sample consisted of consecutive patients evaluated in the period from 1989 to2009 in an Onco-Hematology Service. Clinical, histological and volumetric datawere collected from the medical records. For analysis, chi-square, Kaplan-Meier,log-rank and Cox regression tests were used. p=0.015) andhistologic types of risk (p=0.008). It was also verified anassociation between the difference between the TVBPQ and TVAPQ and the predominantstromal tumor (p=0.037). When assessing the TVAPQ of allpatients, without a cutoff, there was an association of the variable with lifetime(p=0.013), i.e., for each increase of 10mL in TVAPQ there wasan average increase of 2% in the risk of death.  The sample consisted of 32 patients, 53.1% were male with a median age atdiagnosis of 43 months. There was a significant association between TVAPQ>500mLand the difference between the TVBPQ and TVAPQ ( Although our results indicate that the TVAPQ could be considered alone as apredictor of poor prognosis regardless of the cutoff suggested in the literature,more studies are needed to replace the histology and staging by tumor size as bestprognostic variable. Most are diagnosed before the age of 5, andthe current expectation is that over 90% of patients will have an excellent outcome. Themajority of children have an asymptomatic and unilateral abdominal mass. Associatedsymptoms may include hematuria and abdominal pain. This last feature should alert to therisk of tumor rupture, a finding associated with local abdominal recurrence. However,large tumors, usually in advanced stages, did not present indication of surgicalintervention and can benefit from preoperative chemotherapy. This may lead to a tumorshrinkage and reduce the chance of complications as tumor rupture.,SociétéInternationale D'oncologie Pédiatrique (SIOP) studies: low-risk,intermediate-risk and high-risk tumors. This classification is based on the percentageof overall necrosis and the predominant cell type in the residual viable tumor.,,,It is now increasingly important to recognize tumors requiring minimal therapy in orderto reduce the burden of treatment and the risk of late effects.The aim of our study was to investigate the relationship of the tumor volume afterpreoperative chemotherapy (TVAPQ) and before preoperative chemotherapy (TVBPQ) withoverall survival at two and at five years, and lifetime.Our sample consisted of consecutive patients evaluated in the period from 1989 to 2009in an Onco-Hematology Service of a reference hospital in southern Brazil. Clinical,histological and volumetric data were collected from the medical records. All patientsunderwent the SIOP protocol treatment of chemotherapy. This protocol uses neoadjuvantchemotherapy to reduce the tumor volume and the risk of intraoperative rupture.,Tumor volume was calculated according to Weirich et alAs for staging, the stages I and II were grouped. Histologic types were classified inlow, intermediate and high-risk, according to the SIOP 2001 cltassification.The association between categorical variables was performed using the chi-square test.Survival curves were obtained by Kaplan-Meier and compared by log-rank test. To evaluatethe effect of the quantitative parameters, the Cox regression analysis was used. Thelevel of significance was set at 5%, and the analyses were performed using SPSS version18.0.During the assessment period, we identified 32 patients with data available on lesionvolume, 53.1% of which were male, with ages at diagnosis ranging from 6 to 87 months(median 43 months). As for the staging, 3.1% were in stage I and V each, and 31.3% instages II, III and IV each. As for histology, two patients were classified as low-risk(completely necrotic tumor after chemotherapy), 27 as intermediate-risk, and two ashigh-risk (one with a predominantly blastematous component after chemotherapy and theother with diffuse anaplasia). In one patient it was not possible to apply theclassification from the data described in the pathological report. Of the patients classified as intermediate risk, three had tumors predominantlyepithelial, and three stromal. Only one patient with tumor of intermediate risk showed apredominantly rhabdomyomatous histological type. Only one patient had tumor rupture atthe time of surgery. The median TVBPQ was 569.1mL  and medianTVAPQ was 149mL . Five patients (15.6%) had TVAPQ>500mL. Of thosepatients, three were older than 4 years, 3 had stage IV disease, 3 had intermediate-riskhistology, and 2 high-risk. Only one of those patients who had TVAPQ>500mL exhibitedtumor with stromal predominance. No patient presented a predominantly epithelial tumoror an associated rhabdomyomatous component.p=0.008). No patient with low risk presented TVAPQ>500mL.Three (11.1%) out of 27 patients at intermediate risk and all high-risk patientsexhibited TVAPQ>500mL (p=0.015). Nine patients (28.1%) had low response (<40%). Ofthose, 4 (44.4%) had TVAPQ>500mL. From the 23 patients who showed a good response(71.9%), only one had TVAPQ>500mL (There was a significant association between the TVAPQ>500mL and histologic types ofrisk (PQ>500mL . There wPQ>500mL . p=0.06) and histologic types of risk(p=0.092). However, there was an association between the differencebetween TVBPQ and TVAPQ and predominantly stromal tumors (p=0.037)(No significant association was found between the difference between TVBPQ and TVAPQ andage of patients (p=0.037). p=0.685), nor at 5 years(p=0.657) (p=0.604), nor at 5 years (p=0.584)(p=0.013), i.e., for eachincrease of 10mL in TVAPQ, there was an average increase of 2% in the risk of death. Wedid not find association of other variables of the study with the survival.There were nine deaths (28.1%) at two years and 10 (31.3%) at five years. Six of themdied due to complications related to the tumor, and four due to occurrence of acutemyeloid leukemia (AML) some months after the end of the treatment with chemotherapy. Thelifetime ranged from 0 to 210 months. The difference between TVBPQ and TVAPQ was notassociated with death at 2 years (p=0.657) . Also, Tp=0.584). Howeverp=0.776). The difference between TVBPQ and TVAPQ was not associatedto predominantly epithelial histology (p=0.144), nor to predominantlyrhabdomyomatous histological type (p=0.659) (The difference between TVBPQ and TVAPQ was not associated with tumor stage(p=0.659) . p=0.556), stage (p=0.301), predominantlyepithelial (p=0.212) and stromal types (p=0.142), andpredominantly rhabdomyomatous histology (p=0.821) (No significant associations were found between TVAPQ>500mL and age(p=0.821) . We coul.The relationship of the TVAPQ and TVBPQ with survival has previously been addressed onlyby Weirich et al,..The frequency of histological types observed in the present study was similar to thatdescribed by Reinhardt et alConversely, Taran et alp=0.092), 21 patients atintermediate risk (77.8%) had good response (≥40%) with adjuvant treatment, whereas thepatients with high risk had a poor response. The association could be demonstrated withstromal predominant tumors (p=0.037). Two of the three cases presentingstromal predominant tumor had poor response to preoperative chemotherapy, which isexpected in those cases, as reported by Weirich et al.,9although there was a poor response to adjuvant chemotherapy in most tumors of epithelialand stromal predominance, none relapsed. According to Verschuur et al,Although we have not demonstrated an association between histologic types of risk andthe difference between TVBPQ and TVAPQ p=0.02, 21 pat11 includedchildren with localized disease. Reinhard et al.11patients with TVAPQ greater than 500mL exhibited a worse outcome than those with smallertumors . Graf et al14 evaluatedonly patients in non-anaplastic stages II and III of WT and verified that time ofrecurrence and overall survival were univariately and multivariately associated withtumor volume at surgery. Although we found that patients with tumor volumes greater than 500mL did not show abetter response to adjuvant chemotherapy, a significant association betweenTVAPQ>500mL and prognosis was not observed, unlike Reinhard et al.9,10 Reinhard et al14 show that TVAPQ could be used as a contributing factor in the riskstratification of patients submitted to treatment. This aspect is currently beingverified in the study protocol SIOP 2001 with intermediate-risk patients.However, other authors, as Taran et al,As showed in the results, the difference between TVBPQ and TVAPQ was not associated todeath at 2 and 5 years. Weirich et alFour patients of our sample presented and died of AML a few months after the end oftreatment. Leukemia has been described as a late effect that may lead to death..Although our results indicate that the TVAPQ could be considered alone as a predictor ofpoor prognosis regardless of the cutoff suggested in the literature, more studies areneeded to replace the histology and staging by tumor size as best prognostic variables.The histology of the viable tumor remaining after preoperative chemotherapy, whoseevaluation was impaired in our study due to the sample size, is still considered thebest parameter for risk stratification of patients, together with staging, as showed byWeirich et al, ,  and O tumor de Wilms (TW) é responsável por cerca de 6% de todos os cânceres infantis e éo tumor renal maligno mais comum na infância. A maioria é diagnosticada antes doscinco anos e a expectativa atual é que mais de 90% dos pacientes terão um excelentedesfecho. A maior parte das crianças tem uma massa abdominal assintomática eunilateral. Sintomas associados podem incluir hematúria e dor abdominal. Essa últimacaracterística deve alertar para o risco de ruptura do tumor, um achado associado àrecidiva abdominal local. No entanto, tumores grandes, geralmente em estágiosavançados, não apresentaram indicação de intervenção cirúrgica e podem se beneficiarde quimioterapia pré-operatória. Isso pode levar à redução tumoral e reduzir o riscode complicações como a ruptura do tumor. and  and  and  and Presentemente é cada vez mais importante reconhecer tumores que exigem terapiamínima, a fim de reduzir a carga do tratamento e o risco de efeitos tardios.O objetivo do nosso estudo foi investigar a relação entre o volume do tumor após aquimioterapia pré-operatória (VTPOS) e antes da quimioterapia pré-operatória (VTPRE)com sobrevida geral aos dois e cinco anos e tempo de vida.Nossa amostra foi composta por pacientes consecutivos avaliados de 1989 a 2009 em umserviço de onco-hematologia de um hospital de referência no sul do Brasil. Os dadosclínicos, histológicos e volumétricos foram coletados a partir dos prontuáriosmédicos. Todos os pacientes foram submetidos a tratamento quimioterápico com oprotocolo da SIOP. Esse protocolo usa quimioterapia neoadjuvante para reduzir ovolume do tumor e o risco de ruptura intraoperatória.O volume do tumor foi calculado de acordo com Weirich et al.,No estadiamento, os estágios I e II foram agrupados. Os tipos histológicos foramclassificados em baixo, intermediário e alto risco, de acordo com a classificaçãoSIOP 2001.log-rank. Para avaliar o efeito dos parâmetros quantitativos, foiusada a análise de regressão de Cox. O nível de significância foi estabelecido em 5%e as análises foram feitas com o programa SPSS, versão 18.0.A associação entre as variáveis categóricas foi feita com o teste do qui-quadrado. Ascurvas de sobrevida foram obtidas pelo método de Kaplan-Meier e comparadas pelo testede Durante o período de avaliação, foram identificados 32 pacientes com dadosdisponíveis de volume de lesão, dos quais 53,1% eram do sexo masculino, com idades aodiagnóstico de seis a 87 meses (mediana de 43). Quanto ao estadiamento, 3,1% eramestágio I e V cada e 31,3% eram estágios II, III e IV cada. Quanto à histologia, doispacientes foram classificados como de baixo risco (tumor completamente necrosado apósa quimioterapia), 27 como de risco intermediário e dois como de alto risco (umcomponente predominantemente blastematoso após a quimioterapia e o outro comanaplasia difusa). Não foi possível aplicar a classificação dos dados descritos norelatório patológico em um paciente.Dos pacientes classificados como de risco intermediário, três tinham tumorpredominantemente epitelial e três estromal. Apenas um paciente com tumor de riscointermediário tinha um tipo histológico predominantemente rabdomiomatoso. Apenas umpaciente apresentou ruptura do tumor no momento da cirurgia. A mediana do VTPRE foide 569,1 mL  e a mediana do VTPOS foi de 149 mL (variação10-1468 mL). Cinco pacientes  tiveram VTPOS > 500 mL. Desses, três tinhammais de quatro anos, três tinham a doença no estágio IV, três tinham histologia derisco intermediário e dois de alto risco. Apenas um desses pacientes que apresentaramVTPOS >500 mL tinha tumor com predominância estromal. Nenhum paciente tinha tumorpredominantemente epitelial ou componente rabdomiomatoso associado.p=0,008). Nenhum paciente com baixo risco apresentou VTPOS> 500 mL. Três  de 27 pacientes de risco intermediário e todos os pacientesde alto risco apresentaram VTPOS > 500 mL . Nove pacientes  tiveram baixaresposta (<40%). Desses, quatro  tiveram VTPOS >500 mL. Dos 23 pacientesque apresentaram uma boa resposta , apenas um apresentou VTPOS > 500 mL e os tipos histológicos de risco. No entanto, houve uma associação entre a diferençaentre VTPRE e VTPOS e os tumores predominantemente estromais  .p=0,685) nem em cincoanos   nem em cinco anos , ou seja, para cada aumento de 10 mL no VTPOShouve um aumento médio de 2% no risco de morte. Não encontramos associação de outrasvariáveis do estudo  com a sobrevivência.Houve nove mortes  em dois anos e 10  em cinco anos. Seis delesmorreram devido a complicações relacionadas ao tumor e quatro devido à ocorrência deleucemia mieloide aguda (LMA), alguns meses após o fim do tratamento comquimioterapia. O tempo de vida variou de 0 a 210 meses. A diferença entre VTPRE eVTPOS não foi associada à morte em dois anos   efig. 1p=0,584) . Noentap=0,776). A diferença entre VTPRE e VTPOS não foi associada àpredominância da histologia epitelial , nem com o tipohistológico predominantemente rabdomiomatoso   .p=0,556), estágio , tipospredominantemente epiteliais  e estromais e histologia predominantemente rabdomiomatosa  . Nãofoi.A relação do VTPOS e VTPRE com a sobrevivência foi abordada anteriormente apenas porWeirich et al.,..A frequência dos tipos histológicos observados no presente estudo foi semelhante àdescrita por Reinhardt et alApesar do pequeno número de pacientes com tipos histológicos de baixo e alto risco emnosso estudo, houve uma associação significativa entre VTPOS >500 mL e os tiposhistológicos de risco. Nenhum dos pacientes de baixo risco e apenas três  comrisco intermediário apresentaram um VTPOS > 500 mL, em contraste com os pacientesde alto risco. Isso sugere que os volumes maiores do que 500 mL tendem a se encaixarnos casos de tumores histológicos de alto risco, assim como aqueles com os volumesmenores do que 500 mL tendem a se encaixar nos casos de baixo risco.Diversamente, Taran et al.p=0,092), 21 pacientes em riscointermediário  tiveram boa resposta (≥40%) com tratamento adjuvante, enquantoos pacientes com alto risco tiveram uma resposta ruim. A associação pode serdemonstrada com tumores predominantemente estromais . Doisdos três casos que apresentavam tumor predominantemente estromal tiveram respostaruim ao tratamento quimioterápico pré-operatório, o que é esperado nesses casos,conforme relatado por Weirich et al. and Embora não tenhamos demonstrado a associação entre os tipos histológicos de risco e adiferença entre VTPRE e VTPOS p=0,02, 21 pacReinhard et al..Embora tenhamos verificado que os pacientes com volume tumoral superior a 500 mL nãomostraram uma melhor resposta à quimioterapia adjuvante, uma associação significativaentre VTPOS > 500 mL e o prognóstico não foi observada, ao contrário de Reinhardet al.. and No entanto, outros autores, como Taran et al.,Como mostrado nos resultados, a diferença entre VTPRE e VTPOS não foi associada àmorte em dois e cinco anos. Weirich et al.Quatro pacientes da nossa amostra apresentaram e morreram devido à LMA alguns mesesapós o fim do tratamento. A leucemia tem sido descrita como um efeito tardio que podeconduzir à morte..Embora nossos resultados indiquem que o VTPOS poderia ser considerado isoladamentecomo um preditor de mau prognóstico, independentemente do ponto de corte sugerido naliteratura, mais estudos são necessários para substituir a histologia e oestadiamento pelo tamanho do tumor como melhores variáveis de prognóstico. Ahistologia do tumor viável remanescente após a quimioterapia pré-operatória, cujaavaliação foi prejudicada em nosso estudo devido ao tamanho da amostra, ainda éconsiderada o melhor parâmetro para a estratificação de risco dos pacientes emconjunto com o estadiamento, como mostram Weirich et al.,


To evaluate the perception of oncology patients and their caregivers upon diagnosis and beginning of the therapy and during palliative care.Faculdade de Medicina do ABC. Clinical and demographic data from patients and their caregivers were collected and questionnaires regarding the elements considered important in relation to the treatment were applied. A cross-sectional study at the oncology and palliative care outpatients clinics of the  We enrolled 32 patients and 23 caregivers that were initiating treatment at the oncology outpatient clinic, as well as 20 patients and 20 caregivers at the palliative care clinic. Regarding the patients treated at the oncology clinic, the issues considered most important were a physician available to discuss the disease and answer questions (84%), trust in the physician (81%), and a physician with accessible language (81%). For their caregivers, the following issues were considered extremely important: trust in the medical team that treats the patients (96%), and the same medical team taking care of their relatives (87%). As to patients treated at the palliative care clinic, trust in the physician (83%), to be with people considered important to them (78%), and to be treated preserving their dignity (72%) were considered extremely important. For their caregivers, to receive adequate information about the disease and the treatment’s risks and benefits (84%), and sincere communication of information about the disease (79%) were considered extremely relevant. Confidence through good communication and consistency in care were fundamental values to achieve satisfaction among caregivers and patients with cancer during all the course of disease development. With new diagnostic and therapeutic methods, it is possible to make early diagnosis, besides increasing survival, guaranteeing a greater number of people living with the disease. However, in detriment of the therapeutic advances and of the increased number of diagnoses in oncology, the mortality rates due to cancer continue to climb: in 2008, 7.6 million people died because of the disease, as per the World Health Organization.Cancer is a universal disease with increasing numbers of patients affected; it is already the second cause of death in the United States Currently, there is a lot of research regarding cancer, but most of it is based on the physician’s perspective, distanced from the doctor-patient relationship and of the benefits that can come when this is adequately established. Additionally, the perspective of the caregivers becomes significant since these patients are a part of a family dynamic, which is altered as of the diagnosis until resolution or the palliative phase, impacting the evolution of the disease. A Canadian study covered the perspective of patients and their caregivers regarding the most important elements related to oncological treatment they are given and the interaction with the healthcare team within the context of palliative care. In Brazil, there is little knowledge of what is really important to oncology patients and their caregivers, not only at the time of the diagnosis of cancer, when they still know little about the disease and have not yet been submitted to treatment, but also during palliative care.This panorama reflects the importance of implementing treatments and interventions for improved quality of life of all oncology patients and their caregivers, of cure whenever possible, and of the care of symptoms – when a cure is no longer an attainable goal.To evaluate the perception of oncology patients and their caregivers at the beginning of their diagnostic and therapeutic approach, and during palliative care; to establish comparisons among patients and subgroups of caregivers in both circumstances, highlighting the convergent and divergent points as to what each group considers most important at the time.Faculdade de Medicina do ABC do Hospital Estadual Mário Covas, in Santo André, SP, and of the Hospital de Ensino Padre Anchieta, in São Bernardo do Campo, SP, were invited to participate during the period from April to June, 2013.After approval by the Institutional Review Board , patients seen at the outpatient clinics for symptom control  and at the first clinical visit at the oncology outpatients clinics of the Patients over 18 years of age with confirmed diagnosis of neoplasm and/or with advanced disease were considered eligible for the study; excluded were those who had a significant cognitive deficit that impeded the application of the questionnaire, as well as the illiterate patients or those not fluent in portuguese. All those who agreed to participate in the study signed the informed consent form (ICF), making clear the voluntary characteristic of their participation. After the decision of the patient to participate in the study, the invitation was extended to the caregivers to also take part.The companions were considered caregivers when they had some degree of bond with the patient, were involved in their treatment, or reported some form of contact with him/her at least once a week. They could be family members or not, as one patient could have more than one caregiver. The ICF was also delivered and signed by the caregivers, as long as they demonstrated the capacity to understand the study text and were aged over 18 years at the time when they were approached. Patients who had no caregivers were invited to participate in the study with no difference relative to those who had caregivers.Clinical and demographic data were collected from the patients, along with demographic data from the caregivers. The clinical questionnaire covered information on the disease, such as type of neoplasm, staging, date of diagnosis, comorbidities, and past clinical/surgical and family history. The data in reference to the disease that patients were not able to inform was obtained from their medical records. As to demographic data, questions were asked about level of schooling, marital status, age, ethnicity, place of residence, place of birth, religion, and level of spirituality. The caregivers were also asked about their degree of kinship or bond with the patient, for those who were not relatives. applied to hospitalized palliative patients. In order for the questionnaires to be applied within the context of our study and of our services, some questions were changed and adapted.Next, the patients and their caregivers received questionnaires in reference to the topics to be included as significant for the treatment. These questionnaires were prepared based on a Canadian studyBasically, the original questionnaire was developed based on a review of literature pertaining to palliative care and additional items, generated from a new review and from a multidisciplinary discussion held at Queen University, in Ontario. This was tested in interviews with a group of 12 severely ill patients, even though eligible for the study, so that the final 28 items were comprehensively tested among healthcare employees and patients and their caregivers in order to attain clarity, objectivity, and sensitivity.For the alterations to be made, the following diverging points were considered: the moment of application , the fact that the individuals were outpatients , and the social economic differences between the two countries .Thus, the questionnaires for patients and caregivers continued to cover the same five domains . The questionnaire that was applied at the time right after the diagnosis contained 22 items for the patients and 17 for the caregivers; whereas the questionnaire applied for patients under palliative care, had 24 items for the patents and 21 for the caregivers.Each one of these items was evaluated as to its importance for the patient or caregiver, using a scale from zero to 4, where zero meant no importance at all, 1 not very important, 2 somewhat important, 3 very important, and 4 extremely important. According to the score given for each item, we listed, in decreasing order, starting from the frequency of the items considered “extremely important”, and these were classified according to the proportion of the responses.During the period of April and May 2013, 32 patients and 23 caregivers who initiated treatment at the oncology outpatients clinics were enrolled. The mean age was 61 years (range: 26 to 84 years) and 43.5 years (range: 26 to 63 years), and the prevalence was of the female gender (56% and 83%), respectively. As to these caregivers and their degree of kinship, 43% of them were sons and daughters. For these patients, the items considered most important were that the physician be available to discuss their illness and answer their questions (84%), the importance of having confidence in the physicians who care for you (81%), and that the physician speak in a manner that you understand with accessible language (81%) . For theDuring the same period, 20 patients and 20 caregivers were included in the symptom-control outpatient clinics, with a mean age of 69 (range: 23 to 84) and 47 (range: 20 to 62) years, respectively. Female prevalence in both groups was 75% and as to degree of kinship between caregiver and patient, 65% of them were sons or daughters. For the patients, the following items were considered extremely important: to have confidence in the physicians that care for you (83%), to be able to have people near who are important to you (78%), and to be treated in a manner that preserves your dignity (72%) . For the the objective of medicine as a profession dedicated to cure and care for the patient in a dignified manner depends on a doctor-patient relationship sustained by trust. For this trust-based doctor-patient relationship to be built, communication must be made in an effective manner, with appropriate attention and language.According to Chin et al., To know how to speak, express oneself with clarity, and be able to communicate the information in the most didactic way possible enables fulfillment of the Hippocratic ideal of the Physician who cares for and can influence his/her patient. In fact, the origin of the word “doctor” is Latin: “d’ocere”, which means to teach. For this, a daily practice of medicine is necessary, having as fundamental pillar, the patient.By means of this study, we were able to determine that the most important elements for the patients, when initiating their treatment, were the availability of the physician to discuss about the disease and answer questions, trust in the physician, and accessible and comprehensible language. The three elements, together, lead to the rhetoric importance of communication between the physician and the patient, giving rise to a relationship of confidence, that conveys credibility, knowledge, and includes donating time. This item is listed as relevant not only in our study,,,11 and in fact, there is a literature review on the satisfaction of patients during their treatment that advocates that the more personalized the care, the better the rates of satisfaction. According to this same study, individualization of treatment makes communication of the patient with the physician better, as well as the involvement of the patient with his/her treatment.According to the caregivers of patients initiating cancer treatment, the most important issues were confidence in the physicians who care for the patient and always having the same medical team caring for the family member. Confidence proves important not only in the relationship with the patient, but also for those inserted into the same context. The second most important element is interesting, since amidst the care given to a certain patient by the same professional or team over time, there is individualization of his/her care. In a study conducted by Thom et al., medical behavior was correlated with patient confidence. These authors interviewed 414 patients who, after clinical visits, would evaluate their physicians as to 18 preestablished behaviors, which allowed an assessment of the degree of trust in these professionals. As a result, the behaviors most often associated with confidence in the physician were demonstration of attention and care, technical competence, and the quality of communication.As for the patients at our palliative care service, the most important item was having confidence in the physician responsible for the treatment, a paramount item for the patients in the Canadian study as well. Nevertheless, to communicate in an adequate form may not be an easy task. A study by Wilmot and Hocker about physicians and healthcare professionals that cared for patients with advanced stage cancer in an American center showed that the most difficult part of their work was communication with the families of the patients. In a systematic review in which 21 papers were included, there was a positive correlation between effectiveness of communication between the physician and patient and the success of the treatment. The aspects that obtained the greatest relationships with adequate communication were pain control, compliance with the treatment, symptom resolution, and emotional health.As to the caregivers of patients under palliative care, the three most important items mentioned in our study refer to quality of communication. In the Canadian study, such a concern of caregivers appeared in third place, and was also a priority.In this way, in order to improve the quality of life of the patients and their caregivers, we need to know what is significantly important for both groups. We note that for patients, having trust in one’s physician, being received in a dignified and humanized manner, and keeping well informed as to one’s illness are priority issues. On the other hand, for the caregivers, most of the items judged as essential reflected the quality of communication with the physicians responsible for the care of their relatives, and that they have adequate control of the symptoms. Along the course of a chronic and potentially lethal disease, such as cancer, we have the opportunity to perceive which values remain important throughout time. Comparing these two studies at different time points of the natural progression of cancer at a given health center, the importance of trust in the healthcare team was clear, both as to diagnosis and in the more advanced phases of the disease. Knowledge of these factors allows a better focus of our efforts on what is, in fact, most important to patients and caregivers, and these same items can also serve as a focus for continuous evaluation, in order to detect our deficiencies and progresses in the same areas.Confidence mediated by good communication and consistency in care are values considered fundamental for the satisfaction of caregivers and patients with cancer along the whole evolution of the illness. Structuring of services to enable longitudinal follow-up of patients and the cultivation of communication skills in medical training are probably the most promising attitudes needed to assure satisfaction of the population of patients with cancer and their caregivers.  e à terceira no Brasil, demonstrando sua importância em termos de saúde pública. Com os novos métodos diagnósticos e terapêuticos, há a possibilidade de um diagnóstico precoce, além de aumento da sobrevida, garantindo um maior número de pessoas convivendo com a doença. No entanto, em detrimento dos avanços terapêuticos e do aumento do número de diagnósticos na oncologia, os índices de mortalidade por câncer continuam aumentando: em 2008, 7,6 milhões de pessoas morreram por causa da doença, segundo a Organização Mundial da Saúde.O câncer é uma doença universal com números crescentes de pessoas acometidas, de modo que já corresponde à segunda causa de morte nos Estados Unidos Atualmente, há muitas pesquisas a respeito do câncer, porém a maioria é baseada na perspectiva do médico, distanciando-se da relação médico-paciente e dos benefícios que podem advir quando esta é estabelecida de forma adequada. Além disso, a perspectiva de seus cuidadores se torna importante, pelo fato de que esses pacientes estão inseridos numa dinâmica familiar, que é alterada a partir do diagnóstico, até a resolução ou a fase paliativa, impactando na evolução de sua doença. Estudo canadense abordou a perspectiva dos pacientes e de seus cuidadores acerca de quais são os elementos mais importantes em relação ao tratamento oncológico que lhes é ministrado e da interação com a equipe de saúde, no contexto de cuidados paliativos. No Brasil, há pouco conhecimento do que realmente importa para os pacientes oncológicos e cuidadores, não só no momento do diagnóstico do câncer, quando ainda desconhecem a doença e não foram submetidos ao seu tratamento, como também durante os cuidados paliativos.Esse panorama reflete a importância de implementar terapêuticas e intervenções em prol da melhor qualidade de vida de todos os pacientes oncológicos e de seus cuidadores, da cura quando possível e do cuidado dos sintomas − quando a cura deixa de ser uma meta exequível.Avaliar a percepção dos pacientes oncológicos e de seus cuidadores no início de sua abordagem diagnóstica e terapêutica, e durante os cuidados paliativos; estabelecer comparações entre os pacientes e os subgrupos de cuidadores nas duas circunstâncias, evidenciando os pontos convergentes e discrepantes, em relação ao que cada grupo considera mais importante em cada momento.Após aprovação pelo Comitê de Ética em Pesquisa da instituição , foram convidados a participar do estudo os pacientes atendidos nos ambulatórios de controle de sintomas  e em primeira consulta nos ambulatórios de oncologia da Faculdade de Medicina do ABC do Hospital Estadual Mário Covas, em Santo André, SP, e do Hospital de Ensino Padre Anchieta, em São Bernardo do Campo, SP, no período de abril a junho de 2013.Foram considerados elegíveis ao estudo os pacientes maiores de 18 anos com diagnóstico confirmado de neoplasia e/ou com doença avançada; foram desconsiderados aqueles que tinham algum défice cognitivo importante que impedisse a aplicação do questionário, bem como os pacientes analfabetos ou não fluentes no português. Todos que concordaram em participar do estudo assinaram o Termo de Consentimento Livre Esclarecido (TCLE), deixando claro o caráter voluntário da participação. Após a decisão do paciente em participar do estudo, estendia-se o convite para que o cuidador também participasse.Os acompanhantes foram considerados cuidadores quando tivessem algum vínculo com o paciente, estivessem envolvidos em seu tratamento ou relatassem algum contato com ele pelo menos uma vez por semana. Eles podiam ser ou não familiares do paciente, sendo que um paciente poderia ter mais de um cuidador. O TCLE também foi entregue e assinado pelos cuidadores, desde que demonstrassem aptidão ao entendimento do texto do estudo e que fossem maiores de 18 anos no ato da abordagem. Os pacientes que não tinham cuidadores foram convidados a participar do estudo sem qualquer diferença em relação àqueles com cuidadores.Foram coletados dados clínicos e demográficos dos pacientes, bem como dados demográficos dos cuidadores. O questionário clínico versou sobre dados da doença, como tipo de neoplasia, estadiamento, data do diagnóstico, comorbidades, antecedentes pessoais e familiares. Os dados referentes à doença que o paciente não soube informar foram obtidos do prontuário do mesmo. Quanto aos dados demográficos, eram interrogados: escolaridade, estado civil, idade, etnia, procedência, naturalidade, religião e o nível de espiritualidade. Aos cuidadores, foi ainda perguntado qual era o grau de parentesco com o paciente ou seu vínculo, para aqueles que não eram familiares. aplicado em pacientes paliativos internados. Para que os questionários pudessem ser aplicados no contexto do nosso estudo e de nossos serviços, algumas questões foram alteradas e adaptadas.Em seguida, foram entregues para os pacientes e seus cuidadores os questionários referentes aos elementos a serem elencados como importantes em relação ao tratamento. Esses questionários foram elaborados com base em um trabalho canadenseBasicamente, o questionário original foi desenvolvido a partir de uma revisão da literatura em cuidados paliativos e itens adicionais, gerados a partir de nova revisão e de uma discussão multidisciplinar, realizada na Universidade Queen, em Ontário. Este foi testado em entrevistas com um grupo de 12 pacientes graves, porém elegíveis ao estudo, para que os 28 itens finais fossem, então, testados de maneira abrangente, entre funcionários da saúde e pacientes e seus cuidadores, de modo a atingir clareza, objetividade e sensibilidade.Para as alterações serem feitas, foram considerados os seguintes pontos divergentes: o momento de aplicação , o fato dos pacientes serem ambulatoriais  e as diferenças socioeconômicas entre os dois países .Assim, os questionários para pacientes e cuidadores continuaram a abordar os mesmos cinco domínios . O questionário que foi aplicado no momento subsequente ao diagnóstico continha 22 itens para os pacientes e 17 para os cuidadores; já o questionário aplicado para pacientes em cuidados paliativos, 24 itens para os pacientes e 21 para os cuidadores.Cada um destes itens foi avaliado quanto à sua importância para o paciente ou cuidador, em uma escala de zero a 4, sendo zero sem importância alguma, 1 não muito importante, 2 um pouco importante, 3 muito importante e 4 extremamente importante. De acordo com a pontuação dada para cada item, elencamos, em ordem decrescente, a partir da frequência dos itens considerados “extremamente importante”, e estes foram classificados de acordo com a proporção das respostas.No período de abril e maio de 2013, foram incluídos 32 pacientes e 23 cuidadores que iniciavam o tratamento nos ambulatórios de oncologia. A média de idade foi de 61 (variação de 26 a 84) e 43,5 (variação de 26 a 63) anos, e a prevalência foi do sexo feminino (56% e 83%), respectivamente. Em relação a esses cuidadores e ao seu grau de parentesco, 43% deles eram filhos. Para esses pacientes, os itens considerados mais importantes foram: que o médico esteja disponível para discutir sua doença e responder suas dúvidas (84%), a importância em ter confiança nos médicos que cuidam de você (81%) e que o médico fale de uma maneira que você compreenda com linguagem acessível (81%) . Para seDurante o mesmo período, foram incluídos 20 pacientes e 20 cuidadores nos ambulatórios de controle de sintomas, sendo a média de idade de 69 (variação de 23 de 84) e de 47 (variação de 20 a 62) anos, respectivamente. A prevalência feminina em ambos os grupos foi de 75% e, em relação ao grau de parentesco do cuidador com o paciente, 65% deles eram filhos. Para os pacientes, foram considerados extremamente importantes: ter confiança nos médicos que cuidam de você (83%), poder estar com as pessoas que são importantes para você (78%) e ser tratado de modo que preserve sua dignidade (72%) . Para os “os objetivos da medicina sendo esta uma profissão dedicada a curar e ao cuidado com o doente de uma forma digna dependem de uma relação médico paciente sustentada na confiança”. Para que haja a construção dessa relação médico-paciente embasada em confiança, é preciso que a comunicação seja feita de maneira efetiva, com atenção e linguagem adequadas.Segundo Chin et al., Saber falar, exprimir-se com clareza e conseguir veicular a informação da maneira mais didática possível nos remete ao ideal hipocrático do Doutor que cuida e que consegue influenciar seu paciente. De fato, a origem da palavra doutor é latina: “d’ocere”, que significa ensinar. Para tal, é necessária a prática diária de uma medicina, cujo pilar fundamental seja o paciente.Por meio desse estudo, pudemos constatar que os elementos mais importantes para os pacientes, ao iniciarem seu tratamento, foram: a disponibilidade do médico para discutir sua doença e responder suas dúvidas, confiança no médico e linguagem acessível e compreensível. Os três elementos, juntos, levam a retórica importância da comunicação entre o médico e seu paciente, fazendo surgir uma relação de confiança, que passe credibilidade, conhecimento e inclua doação de tempo. Esse item é listado como relevante não só no nosso estudo,11 e, de fato, há uma revisão da literatura sobre a satisfação dos pacientes durante seu tratamento que advoga que, quanto mais personalizado, maiores são seus índices de satisfação. Segundo esse mesmo estudo, a individualização do tratamento faz com que comunicação do paciente com os médicos seja melhor, assim como o envolvimento do paciente com seu tratamento.Segundo os cuidadores dos pacientes que iniciavam o tratamento oncológico, as questões mais importantes foram: confiança nos médicos que cuidam do paciente e ter sempre a mesma equipe médica cuidando de seu familiar. A confiança se mostra importante não só na relação com o paciente, como também para aqueles inseridos no mesmo contexto. O segundo elemento mais importante é interessante, pois, por meio do cuidado de um dado paciente por um mesmo profissional ou equipe ao longo do tempo, há a individualização de seu cuidado. Em um estudo conduzido por Thom et al., foi correlacionado o comportamento médico com a confiança dos pacientes. Esses autores entrevistaram 414 pacientes que, após consulta, avaliavam seus médicos em relação a 18 comportamentos preestabelecidos, o que permitiu a avaliação do grau de confiança nesses profissionais. Como resultado, os comportamentos mais associados com a confiança no médico foram: demonstrar atenção e cuidado, competência técnica e a qualidade de sua comunicação.Já para os pacientes de nosso serviço em cuidados paliativos, o item mais importante foi ter confiança no médico responsável por seu tratamento, item primordial também para os pacientes do estudo canadense. No entanto, comunicar-se de forma adequada pode não ser uma tarefa fácil. Estudo de Wilmot e Hocker acerca de médicos e profissionais de saúde que cuidavam de pacientes com câncer em estágio avançado em um centro americano revelou que a parte mais difícil de seus trabalhos era a comunicação com as famílias dos pacientes. Em uma revisão sistemática, em que foram incluídos 21 trabalhos, observou-se correlação positiva entre a efetividade da comunicação entre médico e paciente e o êxito do tratamento. Os aspectos que obtiveram maiores relações com a adequada comunicação foram: controle da dor, aderência ao tratamento, resolução dos sintomas e a saúde emocional.Em relação aos cuidadores de pacientes em cuidados paliativos, os três itens mais importantes lembrados em nosso estudo referiram-se à qualidade da comunicação. No estudo canadense, tal preocupação dos cuidadores apareceu em terceiro lugar, sendo também uma prioridade.Deste modo, para que possamos melhorar a qualidade de vida dos pacientes e de seus cuidadores, temos que conhecer o que é primordial para ambos os grupos. Percebemos que, para pacientes, ter confiança em seu médico, ser acolhido de forma digna e humanizada e manter-se bem informado sobre sua doença são questões prioritárias. Já para cuidadores, a maior parte dos itens julgados como essenciais refletiu a qualidade da comunicação com os médicos responsáveis pelo cuidado de seus parentes e que estes tivessem adequado controle de seus sintomas. Na trajetória de uma doença crônica e potencialmente letal, como o câncer, temos a oportunidade de perceber quais os valores que permanecem importantes ao longo do tempo. Comparando esses dois estudos em momentos diferentes da evolução natural do câncer em um mesmo serviço de saúde, ficou evidente a importância da confiança na equipe de saúde, tanto ao diagnóstico como nas fases mais avançadas da doença. O conhecimento desses fatores permite melhor focar nossos esforços no que é, de fato, mais importante para pacientes e cuidadores, e esses mesmos itens podem ainda servir como foco de avaliação contínua, para detectar nossas deficiências e progressos nesses mesmos quesitos.A confiança mediada por uma boa comunicação e a constância do cuidado são valores tidos como fundamentais para satisfação de cuidadores e de pacientes com câncer durante toda a evolução da doença. A estruturação dos serviços para viabilizar o seguimento longitudinal dos pacientes e o cultivo de habilidades comunicativas na formação médica são, provavelmente, as atitudes mais promissoras para assegurar a satisfação da população de pacientes com câncer e seus cuidadores.