Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting

Substantial improvements in survival have been seen in multiple myeloma (MM) over recent years, associated with the introduction and widespread use of multiple novel agents and regimens, as well as the emerging treatment paradigm of continuous or long-term therapy. However, these therapies and approaches may have limitations in the community setting, associated with toxicity burden, patient burden, and other factors including cost. Consequently, despite improvements in efficacy in the rigorously controlled clinical trials setting, the same results are not always achieved in real-world practice. Furthermore, the large number of different treatment options and regimens under investigation in various MM settings precludes the feasibility of obtaining head-to-head clinical trial data, and there is a temptation to use cross-trial comparisons to evaluate data across regimens. However, multiple aspects, including patient-related, disease-related, and treatment-related factors, can influence clinical trial outcomes and lead to differences between studies that may confound direct comparisons between data. In this review, we explore the various factors requiring attention when evaluating clinical trial data across available agents/regimens, as well as other considerations that may impact the translation of these findings into everyday MM management. We also investigate discrepancies between clinical trial efficacy and real-world effectiveness through a literature review of non-clinical trial data in relapsed/ refractory MM on novel agent−based regimens and evaluate these data in the context of phase 3 trial results for recently approved and commonly used regimens. We thereby demonstrate the complexity of interpreting data across clinical studies in MM, as well as between clinical studies and routine-care analyses, with the aim to help clinicians consider all the necessary issues when tailoring individual patients’ treatment approaches

Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting

Substantial improvements in survival have been seen in multiple myeloma (MM) over recent years, associated with the introduction and widespread use of multiple novel agents and regimens, as well as the emerging treatment paradigm of continuous or long-term therapy. However, these therapies and approaches may have limitations in the community setting, associated with toxicity burden, patient burden, and other factors including cost. Consequently, despite improvements in efficacy in the rigorously controlled clinical trials setting, the same results are not always achieved in real-world practice. Furthermore, the large number of different treatment options and regimens under investigation in various MM settings precludes the feasibility of obtaining head-to-head clinical trial data, and there is a temptation to use cross-trial comparisons to evaluate data across regimens. However, multiple aspects, including patient-related, disease-related, and treatment-related factors, can influence clinical trial outcomes and lead to differences between studies that may confound direct comparisons between data. In this review, we explore the various factors requiring attention when evaluating clinical trial data across available agents/regimens, as well as other considerations that may impact the translation of these findings into everyday MM management. We also investigate discrepancies between clinical trial efficacy and real-world effectiveness through a literature review of non-clinical trial data in relapsed/ refractory MM on novel agent−based regimens and evaluate these data in the context of phase 3 trial results for recently approved and commonly used regimens. We thereby demonstrate the complexity of interpreting data across clinical studies in MM, as well as between clinical studies and routine-care analyses, with the aim to help clinicians consider all the necessary issues when tailoring individual patients’ treatment approaches

Ethical Decision-Making: A Case for the Triple Font Theory

This paper discusses the philosophical argument and the application of the Triple Font Theory (TFT) for moral evaluation of human acts and attempts to integrate the conceptual components of major moral theories into a systematic internally consistent decision-making model that is theoretically driven. The paper incorporates concepts such as formal and material cooperation and the Principle of Double Effect (PDE) into the theoretical framework. It also advances the thesis that virtue theory ought to be included in any adequate justification of morality and the need to integrate or coordinate notions of virtue into various act-oriented or principles-based ethics. The TFT offers a comprehensive and practical approach to ethical decision-making and is a useful alternative embedded in traditional wisdom. This paper provides a more general framework of the TFT than traditionally presented. Practical judgment is shown to play a constitute role in providing a guide for right action and is the “glueâ€\x9D that integrates the various components of the TFT. Copyright Springer Science+Business Media, Inc. 2007Triple Font Theory, virtue ethics, ethical decision-making, formal and material cooperation, Principle of Double Effect, ethical theories, practical judgment,

O USO DO JOGO EDUCATIVO NO ENSINO DA ENFERMAGEM

In this article, an extensive review of the literature is presented concerned with the educative games as teaching strategy for general education and specifically for nursing education which includes: teaching, health education and continuing education.É apresentada ampla revisão de literatura sobre o uso do jogo educativo como estratégia de ensino na educação em geral e, mais especificamente na enfermagem-ensino, educação para a saúde e educação continuada