A transição para a assimetria regulatória e os mecanismos de sustentabilidade deste modelo: uma análise dos aeroportos concedidos e dos aeroportos autorizados

O presente estudo destina-se à análise do modelo de assimetria regulatória, a partir de dois problemas pontuais, quais sejam: os mecanismos necessários para se obter um ambiente assimétrico, bem como a maneira pela qual se deve orquestrar tal modelo, de forma a compatibilizar uma convivência sustentável em uma estrutura híbrida de competição. Observar-se-á a maneira pela qual pode ser promovida a alteração de um ambiente de simetria regulatória para um ambiente de assimetria, resguardando os direitos e obrigações dos prestadores de determinada atividade, inseridos naquela seara. Ademais, buscar-se-á sugerir instrumentos legais para se permitir a composição de dois meios de exploração de determinada atividade econômica, um que se dê segundo o direito público (publicatio); e outro, que se relacione com o direito privado (ordenatio); compreendendo assim, a dita assimetria regulatória. A título ilustrativo, adentrar-se-á na verificação da medida provisória (MP) 656/14 - a qual previa um possível modelo em que se teria duas ofertas de infraestrutura aeroportuária - para melhor exemplificar como, juridicamente, pode-se viabilizar esta disposição de prestação dual, via poder público (ou delegatários), segundo a forma de concessão; e iniciativa privada, segundo a forma de autorização.

O poder da caneta: a Medida Provisória no processo legislativo estadual

A Medida Provisória (MP) brasileira é um dos instrumentos legislativos mais poderosos nas mãos do Presidente da República para alterar unilateralmente o status quo. Apesar de o judiciário ter reconhecido a competência dos governadores para instituir e adotar a MP, esta existe apenas em seis estados. O artigo procura explicar a não adoção deste instrumento legislativo pela maioria dos estados. Enfatiza-se a escassa ou marginal relevância que é dada à MP pelo governador nos seis casos que a adotaram. Defende-se, aqui, que os governadores, diferentemente dos presidentes, não necessitam de mais um instrumento legislativo ou da ampliação da delegação de prerrogativas legislativas para garantir sua agenda frente a seus respectivos legislativos, já que com ou sem poder de decreto estadual os governadores controlariam a já limitada agenda decisória nos estados.

Materno-infantilism, feminism and maternal health policy in Brazil

In the last days of 2011, President of Brazil Dilma Rousseff issued a provisional measure (or draft law) entitled "National Surveillance and Monitoring Registration System for the Prevention of Maternal Mortality" (MP 557), as part of a new maternal health programme. It was supposed to address the pressing issue of maternal morbidity and mortality in Brazil, but instead it caused an explosive controversy because it used terms such as nascituro (unborn child) and proposed the compulsory registration of every pregnancy. After intense protests by feminist and human rights groups that this law was unconstitutional, violated women's right to privacy and threatened our already limited reproductive rights, the measure was revised in January 2012, omitting "the unborn child" but not the mandatory registration of pregnancy. Unfortunately, neither version of the draft law addresses the two main problems with maternal health in Brazil: the over-medicalisation of childbirth and its adverse effects, and the need for safe, legal abortion. The content of this measure itself reflects the conflictive nature of public policies on reproductive health in Brazil and how they are shaped by close links between different levels of government and political parties, and religious and professional sectors. (C) 2012 Reproductive Health Matters

Oposição e obstrução na Câmara dos Deputados

Investiga o Regimento Interno da Câmara dos Deputados com o objetivo de verificar se suas regras favorecem excessivamente a prática da obstrução, o que pode levar ao desequilíbrio da disputa parlamentar em favor daqueles - sobretudo os oposicionistas - que decidem obstruir as deliberações mediante a utilização de táticas protelatórias. O estudo centra sua análise na quantidade de tempo gasto com a votação dos diversos mecanismos de obstrução, tendo em vista o tempo regimental disponível para a Ordem do Dia, fase da sessão destinada exclusivamente à discussão e votação das diversas propostas legislativas. O objetivo é apurar se o tempo despendido com artifícios procrastinatórios (requerimentos, dentre outros) supera em demasia o destinado à apreciação da matéria principal. Na apreciação de medidas provisórias (MP), por exemplo, os cálculos efetuados nas simulações demonstram que a votação dos requerimentos, por si só, pode consumir mais da metade do tempo utilizado para votar uma única MP, o que foi confirmado pelos resultados verificados na análise dos casos concretos selecionados.

O regime brasileiro de tributação de lucros auferidos por sociedades controladas e coligadas no exterior: uma visão do atual regime por meio da ótica da teoria do rent seeking

O presente trabalho tem por objetivo analisar, pela ótica da teoria do rent seeking, a evolução da legislação e da jurisprudência administrativa e judicial acerca do regime da tributação dos lucros, ganhos de capital e rendimentos auferidos por sociedades controladas e coligadas no exterior. Observar-se-á a hipótese da legislação e das suas diversas interpretações refletirem interesses predominantemente de apropriação de renda, tanto por parte da Administração Pública quanto dos agentes privados. Nesse sentido, após uma exposição da teoria do rent seeking e da sua relação com a teoria do patrimonialismo no Brasil, ela será aplicada no tema tributário proposto. Para tanto, verificar-se-á a evolução da legislação até o último diploma normativo relevante sobre o tema: a Medida Provisória nº 2.158-35/01. Neste momento, serão identificadas as principais controvérsias e os possíveis interesses nas diversas interpretações dadas às regras em questão, associando-os com os diversos problemas de rent seeking observáveis. A seguir, verificar-se-á, nas decisões do Superior Tribunal de Justiça (STJ), do Supremo Tribunal Federal (STF), e do Conselho Administrativo de Recursos Fiscais (CARF) qual a evolução do entendimento dos tribunais a respeito das referidas interpretações, verificando se algum consenso foi atingido e quais interesses estariam atingidos pelo rumo tomado pela jurisprudência sobre o tema. Neste contexto, a análise da evolução legislativa e jurisprudencial abordará os seguintes pontos controversos: (1) caracterização das regras brasileiras como CFC rules (característica antielisiva); (2) tributação de distribuição ficta ou de lucro da própria controladora ou coligada no Brasil; (3) constitucionalidade do artigo 43, parágrafo 2º, do Código Tributário Nacional, bem como do artigo 74 da Medida Provisória nº 2.158-35/01; e (4) a compatibilização com os Tratados contra a Dupla Tributação. Por fim, far-se-á uma conclusão, a partir dos resultados verificados, a respeito de como a evolução das regras tributárias em questão pode representar uma apropriação de renda sem benefícios públicos que pode favorecer indevidamente tanto o setor público como o privado.

Aspectos polêmicos da arbitragem: as tutelas de urgência no âmbito do procedimento arbitral

Através do presente trabalho, buscar-se-á discorrer sobre o cabimento das tutelas de urgências na esfera do procedimento arbitral, englobando a possibilidade de decretação e execução das medidas urgentes pelo árbitro – seja previamente ou no curso da arbitragem –, a partir da análise dos dispositivos da Lei de Arbitragem (Lei nº 9.307/1996), bem como da doutrina nacional dominante sobre o tema. Tal estudo faz-se relevante na medida em que o processo arbitral vem sendo amplamente utilizado por particulares como meio eficaz de solução de litígios relativos a direitos patrimoniais disponíveis. Todavia, mesmo sendo dotada de maior celeridade do que o provimento judicial, nem sempre a arbitragem conseguirá tutelar o direito material alegado pelas partes até que seja proferida a decisão final de mérito. Assim, em algumas situações, nas quais haja fundado receio de dano irreparável à parte, as medidas de urgência são imprescindíveis a fim de assegurar o direito pleiteado, tornando possível a prolação de uma sentença justa e revestida de utilidade prática. Neste contexto, entende-se o árbitro é dotado de poder jurisdicional para conceder medidas cautelares e antecipatórias que se façam necessárias, ainda que tal poder não esteja expressamente delimitado na convenção de arbitragem. Para efetivá-las, no entanto, precisará recorrer ao Poder Judiciário (monopolizador do poder de coerção) para dar cumprimento às medidas decretadas pelo árbitro, sempre que a parte em face da qual a medida for decretada se recusar a cumprir a determinação arbitral espontaneamente.

Representações sociais de discentes sobre universidade: um estudo psicossocial entre ingressantes do vestibular e da seleção ProUni

Demand for access to higher education to put in test the education Brazilian system in view of the surplus of selective processes of public universities, people without option to pay their studies at this education level. In this context, it has arisen the University for All(Universidade para Todos)Program, the ProUni, from Ministry of Education - MEC, created by the Federal Government in 2004, and that it aims the granting of full and partial scholarships in private higher education institutions, graduate courses in sequential specific training, low-income Brazilians students who do not have higher-level degree. Created by the Provisional Measure No 213/2004 and institutionalized by Law No. 11096 of January 13, 2005, the ProUni offers, however, the exemption of some taxes to those institutions that join the program. This is one of the privileged time for the study of Social Representations by offering the researcher, a living laboratory, natural environment, the confrontation between the established and new. In time like this people are challenged to incorporate the new system to the pre-existing one, aiming it through a strangeness of what was so familiar. It is through this game of social forces that we developed the present study with 196 entering higher education, of these are 116 of selective vestibular system and 80 of the ProUni selective system. We opt by the procedures for data collection in order to have access to the circulating senses, in addition to the streamlined responses. With foundation in Abric, we perform the test the Free Association of Words, then analysed by the software and by EVOC Content of the type theme as Bardin. Besides, we require of the subjects, a writing on the study object university later analysed by the software ALCESTE. The results point out to a representation strongly rooted in social factors such as more traditional socio-cultural elements: the beliefs, values, the symbols. It is unique in both groups of subjects: among those entering by the selective ProUni system, there was a stronger anchor in that it does not make inquiries about the program. At the same time, there is a stronger presence of objectivation, entering the selective vestibular system in order that they explained with a value judgement on the programme. It is suggested further studies considering the embryonic state of social representation, as recent as the social purpose that triggered. It would be relevant even the replication of the same research with other people in order to strengthen the power of the theorising of empiria available

Sob a vigência da Ancine (2001-2011): trajetória, mecanismos e a ingerência da economia da cultura na cinematografia

Pós-graduação em Ciências Sociais - FCLAR

O Estado e a aplicação de atos legistativos contrários ao princípio da reserva da lei penal

Pós-graduação em Direito - FCHS

A influência do estado no crescimento da economia do setor mineral: o caso da CVRD de 1942 a 2010

O presente trabalho tem como tema “a influência do Estado no crescimento da economia do setor mineral: o caso da CVRD de 1942 a 2010”. Para orientar a pesquisa e a construção da tese foi estabelecido o problema: que mudanças ocorreram no plano legal e institucional, no Brasil e no Pará, a partir de 1990, que podem ser interpretadas como componentes de um novo modo de regulação e que transformações se processaram na economia, no Brasil e no Pará, que podem ser interpretadas como parte do processo de constituição de um novo regime de acumulação e de que forma essas alterações estão relacionadas com o processo de privatização e crescimento da mineração, sob a gestão da CVRD ou Vale? Como marco teórico operou-se com as categorias de análise regime de acumulação e modo de regulação, considerando as contribuições de Lipetz (1988) e Harvey (1998) da denominada escola da regulação. O objetivo era compreender as mudanças na economia e na legislação, no Brasil e no Pará, como uma transição do regime de acumulação e modo de regulação fordista-keyneiano para um novo regime denominado de acumulação flexível. Selecionou-se um conjunto de eventos para serem analisados como integrantes da transição no modo de regulação: Plano de estabilização econômica; reforma constitucional de 1995; Lei Complementar n° 87/96 - a Lei Kandir; Medida Provisória nº 2166/67 que criou o conceito de obras de utilidade pública; Resolução do Conama nº 369 sobre mineração em Área de Preservação permanente; Lei de responsabilidade Fiscal; Lei de Modernização dos Portos. Outros eventos foram selecionados e analisados como componentes de um novo regime de acumulação: Investimento público em obras de infra-estrutura de transporte e energia; privatização no Brasil, incluindo a da CVRD e sua expansão posterior, juntamente com o crescimento da economia do setor mineral. Concluiu-se que, com a influência do Estado há a estabilização de um novo regime de acumulação, que no Pará aprofunda o perfil primário-exportador da economia. Em 2010, o setor mineral contribuiu com 86% da pauta de exportação e desse total a indústria extrativa mineral participou com 77% e a indústria da transformação com 23%. No período de 2002 a 2007, a indústria extrativa mineral participava com 60% e a da transformação com 40% da exportação. A CVRD ou Vale, no Pará, a partir de 2010, priorizou a exportação de produtos primários, sobretudo minério de ferro, reduzindo sua participação na indústria de transformação, por meio do repasse à Norsk Hidro, de suas ações, na Albrás, Alunorte e Companhia de Alumina do Pará.

Mídia radical: análise comparativa entre a opinião da grande imprensa e da mídia radical no novo código florestal

The objective of this work is to compare how manifests the ideological positioning in the hegemonic media productions, according to Gramsci's conception, in relation to the radical alternative media, proposed by John Downing. The research has as opinionated content sample printed newspaper O Estado de s. Paulo, contrasting with the expressions of NON-PROFIT bauruense environmental “Instituto Ambiental Vidágua on the proposals of the new Brazilian forest Code. The analysis will hold in an interval between the adoption of the code by the Chamber of deputies in April 2012, and the provisional measure of President Dilma Rousseff with 32 modifications, after vetoing 12 articles proposed initially in may 2012. To support the study, will be crafted Gramsci hegemony; What is the alternative and radical media as it manifests itself; the relationship between the environmental journalism with the environmental NGOs; opinionated journalism and journalistic genres opinionated; theories of journalism and framing of matter

The experiences of learner drivers, provisional drivers and supervisors with graduated driver licensing in two Australian jurisdictions

Newly licensed drivers on a provisional or intermediate licence have the highest crash risk when compared with any other group of drivers. In comparison, learner drivers have the lowest crash risk. Graduated driver licensing is one countermeasure that has been demonstrated to effectively reduce the crashes of novice drivers. This thesis examined the graduated driver licensing systems in two Australian states in order to better understand the behaviour of learner drivers, provisional drivers and the supervisors of learner drivers. By doing this, the thesis investigated the personal, social and environmental influences on novice driver behaviour as well as providing effective baseline data against which to measure subsequent changes to the licensing systems. In the first study, conducted prior to the changes to the graduated driver licensing system introduced in mid-2007, drivers who had recently obtained their provisional licence in Queensland and New South Wales were interviewed by telephone regarding their experiences while driving on their learner licence. Of the 687 eligible people approached to participate at driver licensing centres, 392 completed the study representing a response rate of 57.1 per cent. At the time the data was collected, New South Wales represented a more extensive graduated driver licensing system when compared with Queensland. The results suggested that requiring learners to complete a mandated number of hours of supervised practice impacts on the amount of hours that learners report completing. While most learners from New South Wales reported meeting the requirement to complete 50 hours of practice, it appears that many stopped practising soon after this goal was achieved. In contrast, learners from Queensland, who were not required to complete a specific number of hours at the time of the survey, tended to fall into three groups. The first group appeared to complete the minimum number of hours required to pass the test (less than 26 hours), the second group completed 26 to 50 hours of supervised practice while the third group completed significantly more practice than the first two groups (over 100 hours of supervised practice). Learner drivers in both states reported generally complying with the road laws and were unlikely to report that they had been caught breaking the road rules. They also indicated that they planned to obey the road laws once they obtained their provisional licence. However, they were less likely to intend to comply with recommended actions to reduce crash risk such as limiting their driving at night. This study also identified that there were relatively low levels of unaccompanied driving (approximately 15 per cent of the sample), very few driving offences committed (five per cent of the sample) and that learner drivers tended to use a mix of private and professional supervisors (although the majority of practice is undertaken with private supervisors). Consistent with the international literature, this study identified that very few learner drivers had experienced a crash (six per cent) while on their learner licence. The second study was also conducted prior to changes to the graduated driver licensing system and involved follow up interviews with the participants of the first study after they had approximately 21 months driving experience on their provisional licence. Of the 392 participants that completed the first study, 233 participants completed the second interview (representing a response rate of 59.4 per cent). As with the first study, at the time the data was collected, New South Wales had a more extensive graduated driver licensing system than Queensland. For instance, novice drivers from New South Wales were required to progress through two provisional licence phases (P1 and P2) while there was only one provisional licence phase in Queensland. Among the participants in this second study, almost all provisional drivers (97.9 per cent) owned or had access to a vehicle for regular driving. They reported that they were unlikely to break road rules, such as driving after a couple of drinks, but were also unlikely to comply with recommended actions, such as limiting their driving at night. When their provisional driving behaviour was compared to the stated intentions from the first study, the results suggested that their intentions were not a strong predictor of their subsequent behaviour. Their perception of risk associated with driving declined from when they first obtained their learner licence to when they had acquired provisional driving experience. Just over 25 per cent of participants in study two reported that they had been caught committing driving offences while on their provisional licence. Nearly one-third of participants had crashed while driving on a provisional licence, although few of these crashes resulted in injuries or hospitalisations. To complement the first two studies, the third study examined the experiences of supervisors of learner drivers, as well as their perceptions of their learner’s experiences. This study was undertaken after the introduction of the new graduated driver licensing systems in Queensland and New South Wales in mid- 2007, providing insights into the impacts of these changes from the perspective of supervisors. The third study involved an internet survey of 552 supervisors of learner drivers. Within the sample, approximately 50 per cent of participants supervised their own child. Other supervisors of the learner drivers included other parents or stepparents, professional driving instructors and siblings. For two-thirds of the sample, this was the first learner driver that they had supervised. Participants had provided an average of 54.82 hours (sd = 67.19) of supervision. Seventy-three per cent of participants indicated that their learners’ logbooks were accurate or very accurate in most cases, although parents were more likely than non-parents to report that their learners’ logbook was accurate (F (1,546) = 7.74, p = .006). There was no difference between parents and non-parents regarding whether they believed the log book system was effective (F (1,546) = .01, p = .913). The majority of the sample reported that their learner driver had had some professional driving lessons. Notwithstanding this, a significant proportion (72.5 per cent) believed that parents should be either very involved or involved in teaching their child to drive, with parents being more likely than non-parents to hold this belief. In the post mid-2007 graduated driver licensing system, Queensland learner drivers are able to record three hours of supervised practice in their log book for every hour that is completed with a professional driving instructor, up to a total of ten hours. Despite this, there was no difference identified between Queensland and New South Wales participants regarding the amount of time that they reported their learners spent with professional driving instructors (X2(1) = 2.56, p = .110). Supervisors from New South Wales were more likely to ensure that their learner driver complied with the road laws. Additionally, with the exception of drug driving laws, New South Wales supervisors believed it was more important to teach safety-related behaviours such as remaining within the speed limit, car control and hazard perception than those from Queensland. This may be indicative of more intensive road safety educational efforts in New South Wales or the longer time that graduated driver licensing has operated in that jurisdiction. However, other factors may have contributed to these findings and further research is required to explore the issue. In addition, supervisors reported that their learner driver was involved in very few crashes (3.4 per cent) and offences (2.7 per cent). This relatively low reported crash rate is similar to that identified in the first study. Most of the graduated driver licensing research to date has been applied in nature and lacked a strong theoretical foundation. These studies used Akers’ social learning theory to explore the self-reported behaviour of novice drivers and their supervisors. This theory was selected as it has previously been found to provide a relatively comprehensive framework for explaining a range of driver behaviours including novice driver behaviour. Sensation seeking was also used in the first two studies to complement the non-social rewards component of Akers’ social learning theory. This program of research identified that both Akers’ social learning theory and sensation seeking were useful in predicting the behaviour of learner and provisional drivers over and above socio-demographic factors. Within the first study, Akers’ social learning theory accounted for an additional 22 per cent of the variance in learner driver compliance with the law, over and above a range of socio-demographic factors such as age, gender and income. The two constructs within Akers’ theory which were significant predictors of learner driver compliance were the behavioural dimension of differential association relating to friends, and anticipated rewards. Sensation seeking predicted an additional six per cent of the variance in learner driver compliance with the law. When considering a learner driver’s intention to comply with the law while driving on a provisional licence, Akers’ social learning theory accounted for an additional 10 per cent of the variance above socio-demographic factors with anticipated rewards being a significant predictor. Sensation seeking predicted an additional four per cent of the variance. The results suggest that the more rewards individuals anticipate for complying with the law, the more likely they are to obey the road rules. Further research is needed to identify which specific rewards are most likely to encourage novice drivers’ compliance with the law. In the second study, Akers’ social learning theory predicted an additional 40 per cent of the variance in self-reported compliance with road rules over and above socio-demographic factors while sensation seeking accounted for an additional five per cent of the variance. A number of Aker’s social learning theory constructs significantly predicted provisional driver compliance with the law, including the behavioural dimension of differential association for friends, the normative dimension of differential association, personal attitudes and anticipated punishments. The consistent prediction of additional variance by sensation seeking over and above the variables within Akers’ social learning theory in both studies one and two suggests that sensation seeking is not fully captured within the non social rewards dimension of Akers’ social learning theory, at least for novice drivers. It appears that novice drivers are strongly influenced by the desire to engage in new and intense experiences. While socio-demographic factors and the perception of risk associated with driving had an important role in predicting the behaviour of the supervisors of learner drivers, Akers’ social learning theory provided further levels of prediction over and above these factors. The Akers’ social learning theory variables predicted an additional 14 per cent of the variance in the extent to which supervisors ensured that their learners complied with the law and an additional eight per cent of the variance in the supervisors’ provision of a range of practice experiences. The normative dimension of differential association, personal attitudes towards the use of professional driving instructors and anticipated rewards were significant predictors for supervisors ensuring that their learner complied with the road laws, while the normative dimension was important for range of practice. This suggests that supervisors who engage with other supervisors who ensure their learner complies with the road laws and provide a range of practice to their own learners are more likely to also engage in these behaviours. Within this program of research, there were several limitations including the method of recruitment of participants within the first study, the lower participation rate in the second study, an inability to calculate a response rate for study three and the use of self-report data for all three studies. Within the first study, participants were only recruited from larger driver licensing centres to ensure that there was a sufficient throughput of drivers to approach. This may have biased the results due to the possible differences in learners that obtain their licences in locations with smaller licensing centres. Only 59.4 per cent of the sample in the first study completed the second study. This may be a limitation if there was a common reason why those not participating were unable to complete the interview leading to a systematic impact on the results. The third study used a combination of a convenience and snowball sampling which meant that it was not possible to calculate a response rate. All three studies used self-report data which, in many cases, is considered a limitation. However, self-report data may be the only method that can be used to obtain some information. This program of research has a number of implications for countermeasures in both the learner licence phase and the provisional licence phase. During the learner phase, licensing authorities need to carefully consider the number of hours that they mandate learner drivers must complete before they obtain their provisional driving licence. If they mandate an insufficient number of hours, there may be inadvertent negative effects as a result of setting too low a limit. This research suggests that logbooks may be a useful tool for learners and their supervisors in recording and structuring their supervised practice. However, it would appear that the usage rates for logbooks will remain low if they remain voluntary. One strategy for achieving larger amounts of supervised practice is for learner drivers and their supervisors to make supervised practice part of their everyday activities. As well as assisting the learner driver to accumulate the required number of hours of supervised practice, it would ensure that they gain experience in the types of environments that they will probably encounter when driving unaccompanied in the future, such as to and from education or work commitments. There is also a need for policy processes to ensure that parents and professional driving instructors communicate effectively regarding the learner driver’s progress. This is required as most learners spend at least some time with a professional instructor despite receiving significant amounts of practice with a private supervisor. However, many supervisors did not discuss their learner’s progress with the driving instructor. During the provisional phase, there is a need to strengthen countermeasures to address the high crash risk of these drivers. Although many of these crashes are minor, most involve at least one other vehicle. Therefore, there are social and economic benefits to reducing these crashes. If the new, post-2007 graduated driver licensing systems do not significantly reduce crash risk, there may be a need to introduce further provisional licence restrictions such as separate night driving and peer passenger restrictions (as opposed to the hybrid version of these two restrictions operating in both Queensland and New South Wales). Provisional drivers appear to be more likely to obey some provisional licence laws, such as lower blood alcohol content limits, than others such as speed limits. Therefore, there may be a need to introduce countermeasures to encourage provisional drivers to comply with specific restrictions. When combined, these studies provided significant information regarding graduated driver licensing programs. This program of research has investigated graduated driver licensing utilising a cross-sectional and longitudinal design in order to develop our understanding of the experiences of novice drivers that progress through the system in order to help reduce crash risk once novice drivers commence driving by themselves.

The Paediatric Rheumatology International Trials Organisation provisional criteria for the evaluation of response to therapy in juvenile dermatomyositis.

Objective To develop a provisional definition for the evaluation of response to therapy in juvenile dermatomyositis (DM) based on the Paediatric Rheumatology International Trials Organisation juvenile DM core set of variables. Methods Thirty-seven experienced pediatric rheumatologists from 27 countries achieved consensus on 128 difficult patient profiles as clinically improved or not improved using a stepwise approach (patient's rating, statistical analysis, definition selection). Using the physicians' consensus ratings as the “gold standard measure,” chi-square, sensitivity, specificity, false-positive and-negative rates, area under the receiver operating characteristic curve, and kappa agreement for candidate definitions of improvement were calculated. Definitions with kappa values >0.8 were multiplied by the face validity score to select the top definitions. Results The top definition of improvement was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 1 of the remaining worsening by more than 30%, which cannot be muscle strength. The second-highest scoring definition was at least 20% improvement from baseline in 3 of 6 core set variables with no more than 2 of the remaining worsening by more than 25%, which cannot be muscle strength (definition P1 selected by the International Myositis Assessment and Clinical Studies group). The third is similar to the second with the maximum amount of worsening set to 30%. This indicates convergent validity of the process. Conclusion We propose a provisional data-driven definition of improvement that reflects well the consensus rating of experienced clinicians, which incorporates clinically meaningful change in core set variables in a composite end point for the evaluation of global response to therapy in juvenile DM.

The Pediatric Rheumatology International Trials Organization American-College-of-Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: Prospective validation of the definition of improvement

Objective. To use the Pediatric Rheumatology International Trials Organization (PRINTO) core set of outcome measures to develop a validated definition of improvement for the evaluation of response to therapy in juvenile systemic lupus erythematosus (SLE).Methods. Thirty-seven experienced pediatric rheumatologists from 27 countries, each of whom had specific experience in the assessment of juvenile SLE patients, achieved consensus on 128 patient profiles as being clinically improved or not improved. Using the physicians' consensus ratings as the gold standard measure, the chi-square, sensitivity, specificity, false-positive and false-negative rates, area under the receiver operating characteristic curve, and kappa level of agreement for 597 candidate definitions of improvement were calculated. Only definitions with a kappa value greater than 0.7 were retained. The top definitions were selected based on the product of the content validity score multiplied by its kappa statistic.Results. The definition of improvement with the highest final score was at least 50% improvement from baseline in any 2 of the 5 core set measures, with no more than 1 of the remaining worsening by more than 30%.Conclusion. PRINTO proposes a valid and reproducible definition of improvement that reflects well the consensus rating of experienced clinicians and that incorporates clinically meaningful change in core set measures in a composite end point for the evaluation of global response to therapy in patients with juvenile SLE. The definition is now proposed for use in juvenile SLE clinical trials and may help physicians to decide whether a child with SLE responded adequately to therapy.

The development of an objective methodology to measure medication adherence to oral thiopurines in paediatric patients with acute lymphoblastic leukaemia - an exploratory study

Aims - To develop a method that prospectively assesses adherence rates in paediatric patients with acute lymphoblastic leukaemia (ALL) who are receiving the oral thiopurine treatment 6-mercaptopurine (6-MP). Methods - A total of 19 paediatric patients with ALL who were receiving 6-MP therapy were enrolled in this study. A new objective tool (hierarchical cluster analysis of drug metabolite concentrations) was explored as a novel approach to assess non-adherence to oral thiopurines, in combination with other objective measures (the pattern of variability in 6-thioguanine nucleotide erythrocyte concentrations and 6-thiouric acid plasma levels) and the subjective measure of self-reported adherence questionnaire. Results - Parents of five ALL patients (26.3%) reported at least one aspect of non-adherence, with the majority (80%) citing “carelessness at times about taking medication” as the primary reason for non-adherence followed by “forgetting to take the medication” (60%). Of these patients, three (15.8%) were considered non-adherent to medication according to the self-reported adherence questionnaire (scored ≥ 2). Four ALL patients (21.1%) had metabolite profiles indicative of non-adherence (persistently low levels of metabolites and/or metabolite levels clustered variably with time). Out of these four patients, two (50%) admitted non-adherence to therapy. Overall, when both methods were combined, five patients (26.3%) were considered non-adherent to medication, with higher age representing a risk factor for non-adherence (P < 0.05). Conclusions - The present study explored various ways to assess adherence rates to thiopurine medication in ALL patients and highlighted the importance of combining both objective and subjective measures as a better way to assess adherence to oral thiopurines.