Exercise Capacity and Respiratory Profile in Patients after Orthopedic Liver Transplantation: a Follow-up Study.

INTRODUCTION: We sought to describe: 1) The influence of orthotopic liver transplantation (OLT) on exercise capacity, pulmonary function and respiratory muscle strength after surgery, 2) The relationship between exercise capacity and symptoms of anxiety and depression. MATERIAL AND METHODS: This is a prospective follow up study conducted with patients submitted to OLT. All patients were assessed before and 1 month after surgery through measurements: six minute walk test (6MWT), 6 min step test (6MST) and HADS (Hospital Anxiety and Depression Scale). FEV1% (forced expiratory volume), maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were measured in the pre-operative and on 1st, 3rd, 5th day and 1 month after surgery. RESULTS: In 77 patients , 6MWD improved 20.2 m (95%CI 8.1-32.3) and 6MST improved 7.8 steps after surgery (95%CI 3.9-11.6). Change in 6 MWD and 6 MST did not correlated with change HADS. The FEV1% at each time point were 88.8 ± 21.3 before surgery, 32.9 ± 9.9 on 1st day, 39.6 ± 11.5 on 3rd day, 46 ± 12.1 on 5th day and 86.6 ± 21.1 one month after surgery. MIP and MEP values at each time point were -67.4 ± 23.2 and 79.7 ± 26 before surgery, -30.8 ± 12.3 and 36.4 ± 15.4 on 1st day, -38.6 ± 14.1 and 43.8 ± 17 on 3rd day, -45.8 ± 15.9 and 49.7 ± 18.7 on 5th day and -67.1 ± 29.4 and 80.9 ± 23.9 one month after surgery. CONCLUSION: Exercise capacity was modestly increased after OLT without any correlation with symptoms of anxiety and depression. Pulmonary function and respiratory muscle strength decreased immediately after liver transplantation, and progressively recovered, returning to baseline values after 1 month.

Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations.

PURPOSE: Mutations in the HRAS (mHRAS) proto-oncogene occur in 4%-8% of patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Tipifarnib is a farnesyltransferase inhibitor that disrupts HRAS function. We evaluated the efficacy of tipifarnib in patients with R/M mHRAS HNSCC. METHODS: We enrolled 30 patients with R/M HNSCC in a single-arm, open-label phase II trial of tipifarnib for mHRAS malignancies; one additional patient was treated on an expanded access program. After an ad hoc analysis of the first 16 patients with HNSCC with mHRAS variant allele frequency (VAF) data, enrollment was limited to those with a mHRAS VAF of ≥ 20% (high VAF). The primary end point was objective response rate. Secondary end points included assessing safety and tolerability. Patients received tipifarnib 600 or 900 mg orally twice daily on days 1-7 and 15-21 of 28-day cycles. RESULTS: Of the 22 patients with HNSCC with high VAF, 20 were evaluable for response at the time of data cutoff. Objective response rate for evaluable patients with high-VAF HNSCC was 55% (95% CI, 31.5 to 76.9). Median progression-free survival on tipifarnib was 5.6 months (95% CI, 3.6 to 16.4) versus 3.6 months (95% CI, 1.3 to 5.2) on last prior therapy. Median overall survival was 15.4 months (95% CI, 7.0 to 29.7). The most frequent treatment-emergent adverse events among the 30 patients with HNSCC were anemia (37%) and lymphopenia (13%). CONCLUSION: Tipifarnib demonstrated encouraging efficacy in patients with R/M HNSCC with HRAS mutations for whom limited therapeutic options exist (NCT02383927).

Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-ß and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase 1 Trial.

INTRODUCTION: The safety and efficacy of bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the transforming growth factor ß (TGF-ß) receptor II (a TGF-ß "trap") fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1), was evaluated in patients with advanced NSCLC. METHODS: This expansion cohort of NCT02517398, an ongoing, phase 1, open-label trial, includes 80 patients with advanced NSCLC that progressed after platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment and those who also have not received previous immunotherapy. Patients were randomized at a one-to-one ratio to receive either bintrafusp alfa 500 mg or the recommended phase 2 dosage of 1200 mg every 2 weeks. The primary end point was the best overall response (by Response Evaluation Criteria in Solid Tumors 1.1 as adjudicated by independent review committee) and was assessed by the objective response rate (ORR). RESULTS: A total of 80 patients were randomized to receive bintrafusp alfa 500 or 1200 mg (n = 40 each). Median follow-up was 51.9 weeks (IQR, 19.6-74.0). The ORR in all patients was 21.3% (17 of 80). The ORR was 17.5% (seven of 40) and 25.0% (10 of 40) for the 500 mg dose and the 1200 mg dose (recommended phase 2 dose), respectively. At the 1200 mg dose, patients with PD-L1-positive and PD-L1-high (≥80% expression on tumor cells) had ORRs of 36.0% (10 of 27) and 85.7% (six of seven), respectively. Treatment-related adverse events occurred in 55 of the 80 patients (69%) and were graded as greater than or equal to 3 in 23 of the 80 patients (29%). Of the 80 patients, eight (10%) had a treatment-related adverse event that led to treatment discontinuation; no treatment-related deaths occurred. CONCLUSIONS: Bintrafusp alfa had encouraging efficacy and manageable tolerability in patients with NSCLC previously treated with platinum.

Multi-professional team's perception of nurses' competences in liver transplantations.

Objective describe the multi-professional team's perception of nurses' competences in liver transplantation programs. METHOD: descriptive study with a qualitative approach. Data were collected through a questionnaire. Participants were 12 professionals of the liver transplantation team of a reference hospital. For result interpretation, the thematic analysis technique was employed. RESULTS: the professionals assessed the competences employed by nurses as proactive, autonomous, creative, humanized, capable of teamwork, decision-making and conflict management. CONCLUSION: this study made it possible to demonstrate that members of the multi-professional team perceived nurses as professionals capable of coordinating and integrating the skills "knowing, doing, being and co-existing", enabling quality care for candidates and receivers of liver transplants, as well as for their families and/or caregivers in all perioperative phases.

Pharmaceutical orientation at hospital discharge of transplant patients: strategy for patient safety.

OBJECTIVE:: To describe and analyze the pharmaceutical orientation given at hospital discharge of transplant patients. METHODS:: This was a cross-sectional, descriptive and retrospective study that used records of orientation given by the clinical pharmacist in the inpatients unit of the Kidney and Liver Transplant Department, at Hospital Universitário Walter Cantídio, in the city of Fortaleza (CE), Brazil, from January to July, 2014. The following variables recorded at the Clinical Pharmacy Database were analyzed according to their significance and clinical outcomes: pharmaceutical orientation at hospital discharge, drug-related problems and negative outcomes associated with medication, and pharmaceutical interventions performed. RESULTS:: The first post-transplant hospital discharge involved the entire multidisciplinary team and the pharmacist was responsible for orienting about drug therapy. The mean hospital discharges/month with pharmaceutical orientation during the study period was 10.6±1.3, totaling 74 orientations. The prescribed drug therapy had a mean of 9.1±2.7 medications per patient. Fifty-nine drug-related problems were identified, in which 67.8% were related to non-prescription of medication needed, resulting in 89.8% of risk of negative outcomes associated with medications due to untreated health problems. The request for inclusion of drugs (66.1%) was the main intervention, and 49.2% of the medications had some action in the digestive tract or metabolism. All interventions were classified as appropriate, and 86.4% of them we able to prevent negative outcomes. CONCLUSION:: Upon discharge of a transplanted patient, the orientation given by the clinical pharmacist together with the multidisciplinary team is important to avoid negative outcomes associated with drug therapy, assuring medication reconciliation and patient safety. OBJETIVO:: Descrever e analisar a orientação farmacêutica oferecida na alta de pacientes transplantados. METÓDOS:: Trata-se de um estudo transversal, descritivo e retrospectivo, que utilizou os registros das orientações realizadas pelo farmacêutico clínico na unidade de internação do Serviço de Transplante Renal e Hepático, Hospital Universitário Walter Cantídio, em Fortaleza (CE), de janeiro a julho de 2014. Foram analisadas, de acordo com sua significância e desfechos clínicos obtidos, as seguintes variáveis registradas no Banco de Dados do Serviço de Farmácia Clínica: orientações farmacêuticas na alta, problemas e resultados negativos relacionados aos medicamentos, e intervenções farmacêuticas realizadas. RESULTADOS:: A primeira alta pós-transplante envolveu toda a equipe multiprofissional, sendo o farmacêutico responsável pela orientação do tratamento medicamentoso. A média de altas/mês com orientação farmacêutica no período do estudo foi de 10,6±1,3, totalizando 74 orientações. O tratamento clínico prescrito teve média de 9,1±2,7 medicamentos por paciente. Foram identificados 59 problemas relacionados aos medicamentos; 67,8% relacionaram-se com a não prescrição do medicamento necessário, acarretando 89,8% de risco de resultados negativos associados aos medicamentos por problema de saúde não tratado. A principal intervenção foi a solicitação de inclusão do medicamento (66,1%), e 49,2% dos medicamentos envolvidos agiam no aparelho digestivo/metabolismo. Todas as intervenções foram classificadas como apropriadas, e 86,4% foram capazes de prevenir o resultado negativo. CONCLUSÃO:: A orientação do farmacêutico clínico junto à equipe multiprofissional no momento da alta do paciente transplantado é importante, pois previne resultados negativos associados à farmacoterapia, garantindo a conciliação medicamentosa e a segurança do paciente.

Multi-professional team's perception of nurses' competences in liver transplantations / Percepción del equipo multiprofesional sobre las competencias del enfermero en el trasplante hepático / Percepção da equipe multiprofissional sobre as competências do enfermeiro no transplante hepático

ABSTRACT Objective describe the multi-professional team's perception of nurses' competences in liver transplantation programs. Method: descriptive study with a qualitative approach. Data were collected through a questionnaire. Participants were 12 professionals of the liver transplantation team of a reference hospital. For result interpretation, the thematic analysis technique was employed. Results: the professionals assessed the competences employed by nurses as proactive, autonomous, creative, humanized, capable of teamwork, decision-making and conflict management. Conclusion: this study made it possible to demonstrate that members of the multi-professional team perceived nurses as professionals capable of coordinating and integrating the skills "knowing, doing, being and co-existing", enabling quality care for candidates and receivers of liver transplants, as well as for their families and/or caregivers in all perioperative phases.

RESUMEN Objetivo: describir la percepción del equipo multiprofesional sobre las competencias del enfermero en el programa de trasplante hepático. Método: estudio descriptivo, con abordaje cualitativo. Datos recolectados mediante cuestionario, con la participación de 12 profesionales del equipo de trasplante hepático de un hospital de referencia. Para la interpretación de resultados, se utilizó técnica de análisis temático. Resultados: los profesionales evaluaron las competencias desarrolladas por el enfermero como proactiva, autónoma, creativa, humanizada, que sabe trabajar en equipo, tomar decisiones y administrar conflictos. Conclusión: este estudio permitió revelar que los miembros del equipo multiprofesional percibían al enfermero como un profesional capaz de articular e integrar los saberes "conocer, hacer, ser y convivir", permitiendo una atención de calidad al candidato y al receptor de trasplante hepático, así como también a sus familiares y/o cuidadores en todas las fases del perioperatorio.

RESUMO Objetivo: descrever a percepção da equipe multiprofissional sobre as competências do enfermeiro no programa de transplante hepático. Método: estudo descritivo com abordagem qualitativa. Os dados foram coletados por meio de questionário com participação de 12 profissionais da equipe do transplante hepático de um hospital de referência. Para interpretação dos resultados, utilizou-se a técnica de análise temática. Resultados: os profissionais avaliaram as competências desenvolvidas pelo enfermeiro como proativa, autônoma, criativa, humanizada, que sabe trabalhar em equipe, tomar decisões e administrar conflitos. Conclusão: este estudo possibilitou revelar que os membros da equipe multiprofissional percebiam o enfermeiro como um profissional capaz de articular e integrar os saberes "conhecer, fazer, ser e conviver", possibilitando uma assistência com qualidade ao candidato e ao receptor de transplante hepático, como também aos seus familiares e/ou cuidadores em todas as fases do perioperatório.

Qualidade de vida pós-transplante hepático com enxerto de doador idoso / Quality of life after liver transplantation with old donor graft

Comparar a qualidade de vida dos pacientes transplantados hepáticos que receberam fígado de doadorcom idade ≤60 ou >60 anos. Métodos: estudo prospectivo, com amostra de 141 receptores de fígado de doadorcom idade igual ou menor de 60 anos e receptores de fígado de doador idoso, em um centro de referência.Utilizou-se instrumento para identificação e o questionário Short Form-36. Foram aplicados os testes t-Studente Mann-Whitney para comparação entre grupos. Resultados: identificaram-se maiores níveis de qualidade devida com diferenças estatisticamente significativas: Grupo A no aspecto social (p=0,02) e o Grupo B com >50meses de transplante (p=0,05) no componente sumarizado físico. Conclusão: a qualidade de vida de receptoresde fígado de doador idoso foi semelhante aos que receberam enxerto de doadores mais jovens na maioria dasdimensões. O tempo de transplante teve impacto positivo na qualidade de vida de receptores idosos...

Pharmaceutical orientation at hospital discharge of transplant patients: strategy for patient safety / Orientação farmacêutica na alta hospitalar de pacientes transplantados: estratégia para a segurança do paciente

ABSTRACT Objective: To describe and analyze the pharmaceutical orientation given at hospital discharge of transplant patients. Methods: This was a cross-sectional, descriptive and retrospective study that used records of orientation given by the clinical pharmacist in the inpatients unit of the Kidney and Liver Transplant Department, at Hospital Universitário Walter Cantídio, in the city of Fortaleza (CE), Brazil, from January to July, 2014. The following variables recorded at the Clinical Pharmacy Database were analyzed according to their significance and clinical outcomes: pharmaceutical orientation at hospital discharge, drug-related problems and negative outcomes associated with medication, and pharmaceutical interventions performed. Results: The first post-transplant hospital discharge involved the entire multidisciplinary team and the pharmacist was responsible for orienting about drug therapy. The mean hospital discharges/month with pharmaceutical orientation during the study period was 10.6±1.3, totaling 74 orientations. The prescribed drug therapy had a mean of 9.1±2.7 medications per patient. Fifty-nine drug-related problems were identified, in which 67.8% were related to non-prescription of medication needed, resulting in 89.8% of risk of negative outcomes associated with medications due to untreated health problems. The request for inclusion of drugs (66.1%) was the main intervention, and 49.2% of the medications had some action in the digestive tract or metabolism. All interventions were classified as appropriate, and 86.4% of them we able to prevent negative outcomes. Conclusion: Upon discharge of a transplanted patient, the orientation given by the clinical pharmacist together with the multidisciplinary team is important to avoid negative outcomes associated with drug therapy, assuring medication reconciliation and patient safety.

RESUMO Objetivo: Descrever e analisar a orientação farmacêutica oferecida na alta de pacientes transplantados. Metódos: Trata-se de um estudo transversal, descritivo e retrospectivo, que utilizou os registros das orientações realizadas pelo farmacêutico clínico na unidade de internação do Serviço de Transplante Renal e Hepático, Hospital Universitário Walter Cantídio, em Fortaleza (CE), de janeiro a julho de 2014. Foram analisadas, de acordo com sua significância e desfechos clínicos obtidos, as seguintes variáveis registradas no Banco de Dados do Serviço de Farmácia Clínica: orientações farmacêuticas na alta, problemas e resultados negativos relacionados aos medicamentos, e intervenções farmacêuticas realizadas. Resultados: A primeira alta pós-transplante envolveu toda a equipe multiprofissional, sendo o farmacêutico responsável pela orientação do tratamento medicamentoso. A média de altas/mês com orientação farmacêutica no período do estudo foi de 10,6±1,3, totalizando 74 orientações. O tratamento clínico prescrito teve média de 9,1±2,7 medicamentos por paciente. Foram identificados 59 problemas relacionados aos medicamentos; 67,8% relacionaram-se com a não prescrição do medicamento necessário, acarretando 89,8% de risco de resultados negativos associados aos medicamentos por problema de saúde não tratado. A principal intervenção foi a solicitação de inclusão do medicamento (66,1%), e 49,2% dos medicamentos envolvidos agiam no aparelho digestivo/metabolismo. Todas as intervenções foram classificadas como apropriadas, e 86,4% foram capazes de prevenir o resultado negativo. Conclusão: A orientação do farmacêutico clínico junto à equipe multiprofissional no momento da alta do paciente transplantado é importante, pois previne resultados negativos associados à farmacoterapia, garantindo a conciliação medicamentosa e a segurança do paciente.

Avaliação da qualidade de vida do paciente transplantado hepático

O aumento da sobrevida com o transplante hepático despertou a preocupação com a qualidade de vida (QV) de pacientes no pós-operatório a curto e longo prazo. O objetivo deste estudo foi avaliar a qualidade de vida dos pacientes transplantados que receberam fígado de doador com idade menor ou igual a sessenta anos e acima de sessenta anos e analizar a influência das variáveis: escore MELD, idade do receptor e tempo decorrido de transplante. Estudoprospectivo, descritivo e analítico, com abordagem quantitativa. Participaram do estudo pacientes submetidos ao transplante hepático no Hospital Universitário Walter Cantídio, no período de 2007 a 2013. Utilizou-se para coleta dos dados formulário para identificação dos participantes da pesquisa e o questionário Short Form-36 (SF-36) para avaliar a QV. A amostra foi composta por 141 participantes, dividida em dois grupos: Grupo A (n=100), composto por receptores que receberam enxerto hepático de doador com idade menor ou igual a 60 anos e Grupo B (n=41), formado por receptores que receberam enxerto hepático de doador com idade acima de 60 anos. No GrupoA,a idade média foi de 52,5 anos, predominou o sexo masculino (71%), a média do tempo de transplante foi 34 meses, a etiologia principal foi cirrose hepática viral (27%) e a média do MELD foi 20. No Grupo B, a idade média foi de 54 anos; predominou o sexo masculino (75,7%), a média do tempo de transplante foi 36 meses, a etiologia principal foi cirrose viral (22%) e a média do MELD foi 20...

Increased survival after liver transplantation aroused concerns with the quality of life (QOL) of patients in the short and long-term postoperative period. The aim of this study was to compare the quality of life of transplant patients who received liver grafts from donors 60 years of age and less with those who received livers from donors older than 60 years and analyze the influence of variables: MELD score, recipient age and time after transplantation. This was a prospective, descriptive and analytical study with a quantitative approach. Participated in the study, patients who underwent liver transplantation between 2007 and 2013 at the Walter Cantídio University Hospital. For data collection it was used a form for identification of research subjects and the Short Form-36 (SF-36) to evaluate QOL. The sample consisted of 141 subjects divided into two groups: Group A (n = 100) composed of recipients who received liver grafts from donors 60 years and less, and Group B (n = 41), composed of recipients receiving liver graft from donors over 60 years. In Group A, the average recipients age was 52.5 years, male prevalent (71%), the average time of transplantation was 34 months, the main cause was viral cirrhosis (27%) and the average MELD was 20...