Improvement In Proportion Of Patients Research Articles

Terapia Dirigida por Catéter con Fibrinólisis Local en Tromboembolismo Pulmonar de Riesgo Intermedio.

Introducción: En pacientes con tromboembolia pulmonar (TEP) aguda, la fibrinólisis arterial local puede tener una relación muy favorable entre beneficio y riesgo. Objetivo: Caracterizar las condiciones epidemiológicas y clínicas de los pacientes con TEP agudo de riesgo intermedio que han recibido indicación urgente de terapia fibrinolítica dirigida por catéter. Métodos: Estudio retrospectivo analítico de pacientes atendidos en la Fundación Cardiovascular de Colombia (período 2012-2016) con diagnóstico de TEP de riesgo intermedio llevados a terapia fibrinolítica mediante catéter pulmonar. Resultados: Se incluyeron 27 casos (26 pacientes, 57±20 años, 52% mujeres). La confirmación de embolia pulmonar aguda se realizó mediante angiotomografía. El 85% de los casos mostró disfunción ventricular derecha en ecocardiografía, en 74% elevación troponina, y en 82% elevación de BNP o pro-BNP. El tiempo puerta-aguja desde el diagnóstico hasta la fibrinólisis fue de 24 horas (RIQ, 43). El tratamiento endovascular incluyó alteplasa (dosis total, 47±18 mg) y fragmentación-aspiración mecánica mediante catéter pulmonar. El 78% de los pacientes mostró disminución de la PAPm >10% del valor inicial [i.e., respondedores, ∆PAPm=-27±11% (-9±5 mmHg)]. Cinco pacientes fueron no-respondedores (∆PAPm=-2±7%, -1±4 mmHg). La estancia en UCI fue de 7 días (1-19), y la hospitalaria 13 días (1-36). No se presentaron complicaciones por sangrado mayor ni de otra índole. La supervivencia a 90 días fue del 100%. Conclusiones: Esta serie demuestra que la fibrinólisis arterial pulmonar indujo una mejoría hemodinámica inmediata en una alta proporción de pacientes con TEP, con un balance beneficio-riesgo favorable y asumible en ausencia de complicaciones atribuibles inmediatas o tardías.

Value frameworks for cancer care: Do they account for potential durable survival with immunotherapies?

6601 Background: Modern immuno-oncologic agents may have the potential to provide durable survival for some patients. Simultaneously, there is growing concern regarding the cost of cancer care, and multiple frameworks have been developed to assess value. The points based framework created by the American Society of Clinical Oncology (ASCO) has a specific threshold, and more points are awarded if substantial durable survival is demonstrated. The objective of this study was to assess if modern immuno-oncologic agents reach defined efficacy thresholds in this framework. Methods: We reviewedall FDA approvals for immuno-oncologic agents since the first approval in 2011. We collected data regarding study endpoints, specifically the parameters defined in the updated ASCO value framework: improvement in proportion of patients alive with the test regimen, and survival rate with standard. We assessed whether bonus points would be rewarded as per the updated ASCO value framework for durable responses demonstrated on the tails of the Kaplan-Meier curves. These parameters were used as an input to check whether each drug reaches the required achievement defined in the framework. Results: 17 indications for four immunotherapy active ingredients were approved by FDA between 2011-2016: ipilimumab, pembrolizumab, nivolumab and atezolizumab. 59% of the approvals rely on survival endpoints such as overall, progression-free, or relapse-free survival. 41% are based on objective response rates. Only one drug (nivolumab indicated for melanoma first-line treatment) was found to fulfill the threshold defined for the survival rate of standard care (above 20%). Six drugs achieved the required level of improvement in proportion of patients alive in the test regimen compared to the standard (above 50%). As there was no overlap between these two groups of drugs, no drug was found to gain the durable survival bonus points defined by the ASCO framework. Conclusions: Durable survival and responses of modern immuno-oncology agents are currently not recognized to be significant by the ASCO value framework. This may be due to insufficient demonstration of efficacy of such agents, or may be due to an inappropriately calibrated value framework.

Lung cancer diagnosis transformation: Aligning the people, processes, and technology sides of the learning system.

50 Background: The Ottawa Hospital, serving a population of 1.2 million across a large geographic area, redesigned its regional lung cancer diagnosis and patient intake process using a systems approach. Although having a strong record of excellent coordinated care, recent challenges had created strains on delivery metrics. Prior to the implementation of the project (October 2014), it took patients a range of 15 – 225 days to get from a referral with a suspicion of lung cancer to initial treatment, with a 90th percentile of 117 days. Methods: An innovative care platform was developed to align the people, processes and technology sides of the regional lung cancer care. It formed a basis for a “learning” system mobilizing the wider community for transformational change. We redesigned 12 main business processes facilitating accurate and timely diagnoses using the Communities of Practice approach, the Lean and Constraints methodology and the IBM business process management technology tools. In a series of rapid learning cycles, 270 technology-enabled actions were logged and resolved to support 57 process changes in workflow. The main patient value outcome was defined as improvement in the monthly proportion of patients receiving initial treatment within provincial targets and a reduction of total wait time. Results: In 14 months, the TOH Lung Cancer Transformation program yielded substantial improvement across all levels of diagnostic process including a 48% reduction in the cumulative wait times from referral to initial treatment (surgical, systemic, radiation), increased patient satisfaction with care coordination, implementation of guideline standards, efficiency gains from more intensive use of hospital resources, and sustained engagement of over 100 regional lung cancer care providers in collaborative learning and knowledge sharing across disciplinary and organizational boundaries. Conclusions: A systems approach can improve the hospital capacity to facilitate and support inter-professional and intra-professional teamwork necessary for the diagnostic process transformation.

Evaluation of the short-term efficacy and safety of biological agents in different rheumatic diseases: a multidisciplinary therapeutic hospital"s experience

There has been a substantial expansion in the possibilities of current therapy for rheumatic diseases (RD) primarily due to the use of genetically engineered biological agents (GEBA). Objective: to evaluate the short-term efficacy and safety of GEBA in patients with different RD. Subjects and methods. The trial included all RD patients receiving GEBA: rituximab (RTM), infliximab (INF), adalimumab, etanercept, tocilizumab, abatacept in 2009-2012. Therapeutic efficiency and safety were evaluated 6 months later. The effect of GEBA was determined as “remission”, “improvement”, and “no response”, by using the parameters peculiar to specific diseases (such as BVAS, DAS28, BASDAI). Results. The trial enrolled 107 patients (49 men and 58 women; mean age 41.5 years) with rheumatoid arthritis (n=34), ANCA-associated vasculitis (n = 34), systemic lupus erythematosus (n=16), cryoglobulinemic vasculitis (n=11), ankylosing spondyloarthritis (n = 8), systemic vasculitis with large artery involvement (n=6), and other RD. All the cases showed severe systemic autoimmune disease refractory to standard immunosuppressive therapy. RTM (n=66) and INF (n = 31) were most frequently used. The high rate of RTM prescription was due to the fact that this drug was given to all patients with ANCA-associated vasculitis, systemic lupus erythematosus, and cryoglobulinemic vasculitis who totaled more than half of the patients included into the trial. The vast majority of them received GEBA for the first time. After the treatment, there was remission in 62 (57.9%) and improvement in 42 (39.3%) cases. Mild or moderate adverse reactions were observed in 22 (20.6%) patients and severe ones were seen in 6 (5.6%). Conclusion. GEBA therapy ensures a significant improvement in a substantial proportion of patients with different RD refractory to standard immunosuppressive therapy.