The major end-points arising from cancer clinical trials are reviewed. These are: tumour response, treatment morbidity, survival with related data, and quality of life. A survey of tumour response data from 81 published clinical trials found the most common statistical test in use to be a Chi squared test of the total response rate, but a total of 21 different statistical methods were used. The various statistical tests available are reviewed, including the Mann-Whitney test and the Chi squared test for trend which make use of all the categories of response and their intrinsic order. The assumptions underlying the tests are described. Theoretical considerations support the Mann-Whitney test as the optimum choice for the analysis of tumour response data. Methods for comparing alternative statistical tests are summarised, and a new method is described which uses a number of typical sets of data to estimate the relative efficiency of two statistical tests by the median value of the square of the ratio of the z-values. Using this technique, and data from the 81 trials, the Mann-Whitney test is found to be around 40% more efficient than the Chi squared test of the total response rate (this increased efficiency is equivalent to increasing the recruitment to the trial by 40%).This practical result is confirmed by mathematical modelling of tumour response using the power relation of the Mann-Whitney test for ordered categorical data, which is derived. Clinical data is found to fit best a shift model which assumes homogeneity of treatment effect across the different grades of response. On the basis of this model, the Mann-Whitney test is found to be 30% to 110% more efficient than a Chi squared test of the total response rate. The similarities of acute morbidity data to tumour response data lead to similar general conclusions on the optimum method of statistical analysis. In a survey of 36 published clinical trials, the most common method of statistical analysis was again a Chi squared test of a dichotomy (such as no morbidity versus morbidity of any grade). Analysis of data from these trials shows the Mann-Whitney test to be more efficient by around 30%.A survey of 81 papers reporting tumour response in clinical trials found that few of them used methods of estimation of the difference between the treatments, or derived confidence intervals of the size of such a difference. Methods of estimation and calculation of confidence intervals were found even less often in a survey of methods of presentation of morbidity results. The possible reasons for this are discussed. It is concluded that the current methods of analysis of tumour response data and many sets of acute treatment morbidity data are not optimum, and a change should be made from the Chi squared test to the Mann-Whitney test. Such a change could be equivalent to an increase in recruitment into many cancer clinical trials of around 40%.

Made available in DSpace on 2016-08-03T16:34:28Z (GMT). No. of bitstreams: 1 DavidPelosini.pdf: 501782 bytes, checksum: ac39bc78319824d683f231d1c6490e78 (MD5) Previous issue date: 2013-03-22 / Resilience is the individual´s ability to adapt oneself positively to the adversities of life, coping and better functioning with them. This construct has been studied for over forty years in Psychiatry with focus on children, but its investigation with adults is more recent. In the sports field studies have hardly begun. The sports arena presents great challenges and constant adversities which athletes have to conquer in order to accomplish professional goals; consequently, they frequently have to deal with their physical and psychological limitations. Therefore, resilience can be an important aspect in the athletes´ professional lives. This study aims at identifying the relationship between resilience and basketball statistics efficiency. Seventy one adult professional and active basketball athletes have volunteered to take part in this research. The variables were assessed through the Evaluation Scale of Resilience EAR a questionnaire of socio demographic data and performance indexes registered by the Paulista Federation of Basketball. The answers from the participants were coded on a spreadsheet of SPSS and submitted to descriptive statistical analyses and to the calculus of Pearson bi-varied correlations so as to identify the associations between the athletes and their level of resilience. The results of the descriptive statistical analysis and the Pearson bi-varied correlation revealed that the athletes demonstrated high level of resilience with emphasis given to persistence in face of difficulties and a positive attitude towards change. Factors which comprise resilience showed no significant correlation regarding the athletes´ efficiency. As the averages were compared through variant analysis, it was noticed that the athletes that had between five and ten years practice presented better efficiency coefficient average. Results also revealed that the athletes, who played less than 8 minutes in a match, produce, on average, lower indexes of statistical efficiency and the athletes who belong to teams of medium results in the classification table are likely to have a better perception of personal competence than the athletes who play in worse placed teams. Resilience factors did not differ in relation to the athletes experience or to the average time spent in the court. The results of this study reveal the need to question whether statistical efficiency indicators are the most adequate criteria to establish the role of resilience in the life of Basketball players and point to the need of further studies regarding the influence of individual characteristics in the professional sports world. / Resiliência remete à habilidade do ser humano de demonstrar êxito diante das adversidades da vida, superá-las e, inclusive, ser fortalecido ou transformado por elas. O construto tem sido estudado há cerca de quarenta anos na Psiquiatria com foco em crianças, mas sua investigação é bem mais recente com a população adulta. No mundo da competição esportiva, os estudos são escassos. O contexto esportivo apresenta altos desafios e adversidades constantes que os atletas precisam vencer para cumprir as metas profissionais; por isso, convivem, muito frequentemente, com seus limites físicos e psicológicos. Assim, a resiliência pode ser um importante aspecto em suas vidas profissionais. Este estudo objetiva descrever os níveis de resiliência dos atletas no Basquetebol e identificar possíveis relações entre resiliência e alguns indicadores de eficiência estatística. Participaram da pesquisa, voluntariamente, 71 atletas profissionais adultos e atuantes da modalidade. As variáveis foram avaliadas por meio da Escala de Avaliação de Resiliência EAR, de um questionário de dados sociodemográficos e de índices de eficiência registrados pela Federação Paulista de Basquetebol. Os resultados de análises estatísticas descritivas e de correlações bivariadas de Pearson permitiram observar que os atletas demonstraram um alto nível de resiliência com destaque para a persistência diante das dificuldades e a aceitação positiva de mudanças. Os fatores que compõem a resiliência não apresentaram correlação significativa no tocante ao coeficiente de eficiência dos atletas. Ao comparar as médias por meio da análise de variância percebeu-se que os atletas que possuíam entre cinco e dez anos de profissão apresentaram melhores médias de coeficiente de eficiência. Os resultados revelam, ainda, que os atletas que atuam menos de 8 minutos na partida, em média, produzem menores índices de eficiência estatística e que os atletas que pertencem às equipes de resultados medianos na tabela de classificação tendem a apresentar maior percepção de competência pessoal que os atletas que atuam nas equipes mais mal colocadas. Os fatores de resiliência não se diferenciam em função da experiência dos atletas, nem do tempo em média que permanecem em quadra. Esses resultados revelam a necessidade de questionar se os indicadores de eficiência estatística seriam os critérios mais adequados para verificar o papel da resiliência na vida de atletas de Basquetebol e apontam para a necessidade de aumentar o número de estudos sobre a influência de características individuais no mundo dos esportes profissionais.