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1.
BMJ Open Respir Res ; 6(1): e000368, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30687504

RESUMO

Introduction: One of the most debilitating symptoms of malignant pleural mesothelioma (MPM) is dyspnoea caused by pleural effusion. MPM can be complicated by the presence of tumour on the visceral pleura preventing the lung from re-expanding, known as trapped lung (TL). There is currently no consensus on the best way to manage TL. One approach is insertion of an indwelling pleural catheter (IPC) under local anaesthesia. Another is video-assisted thoracoscopic partial pleurectomy/decortication (VAT-PD). Performed under general anaesthesia, VAT-PD permits surgical removal of the rind of tumour from the visceral pleura thereby allowing the lung to fully re-expand. Methods and analysis: MesoTRAP is a feasibility study that includes a pilot multicentre, randomised controlled clinical trial comparing VAT-PD with IPC in patients with TL and pleural effusion due to MPM. The primary objective is to measure the SD of visual analogue scale scores for dyspnoea following randomisation and examine the patterns of change over time in each treatment group. Secondary objectives include documenting survival and adverse events, estimating the incidence and prevalence of TL in patients with MPM, examining completion of alternative forms of data capture for economic evaluation and determining the ability to randomise 38 patients in 18 months. Ethics and dissemination: This study was approved by the East of England-Cambridge Central Research Ethics Committee and the Health Research Authority (reference number 16/EE/0370). We aim to publish the outputs of this work in international peer-reviewed journals compliant with an Open Access policy. Trial registration: NCT03412357.


Assuntos
Neoplasias Pulmonares/cirurgia , Mesotelioma/cirurgia , Derrame Pleural Maligno/cirurgia , Neoplasias Pleurais/cirurgia , Pleurodese/métodos , Cirurgia Torácica Vídeoassistida/métodos , Adulto , Cateteres de Demora , Ensaios Clínicos Fase III como Assunto , Inglaterra/epidemiologia , Estudos de Viabilidade , Feminino , Humanos , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/mortalidade , Masculino , Mesotelioma/complicações , Mesotelioma/mortalidade , Mesotelioma Maligno , Estudos Multicêntricos como Assunto , Estudos Observacionais como Assunto , Projetos Piloto , Derrame Pleural Maligno/etiologia , Derrame Pleural Maligno/mortalidade , Neoplasias Pleurais/complicações , Neoplasias Pleurais/mortalidade , Pleurodese/efeitos adversos , Pleurodese/instrumentação , Ensaios Clínicos Controlados Aleatórios como Assunto , Tamanho da Amostra , Análise de Sobrevida , Cirurgia Torácica Vídeoassistida/efeitos adversos , Cirurgia Torácica Vídeoassistida/instrumentação , Resultado do Tratamento
2.
Trials ; 15: 367, 2014 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-25238873

RESUMO

BACKGROUND: Malignant pleural mesothelioma is an incurable cancer caused by exposure to asbestos. The United Kingdom has the highest death rate from mesothelioma in the world and this figure is increasing. Median survival is 8 to 12 months, and most patients have symptoms at diagnosis. The fittest patients may be offered chemotherapy with palliative intent. For patients not fit for systemic anticancer treatment, best supportive care remains the mainstay of management. A study from the United States examining advanced lung cancer showed that early specialist palliative care input improved patient health related quality of life and depression symptoms 12 weeks after diagnosis. While mesothelioma and advanced lung cancer share many symptoms and have a poor prognosis, oncology and palliative care services in the United Kingdom, and many other countries, vary considerably compared to the United States. The aim of this trial is to assess whether regular early symptom control treatment provided by palliative care specialists can improve health related quality of life in patients newly diagnosed with mesothelioma. METHODS: This multicentre study is an non-blinded, randomised controlled, parallel group trial. A total of 174 patients with a new diagnosis of malignant pleural mesothelioma will be minimised with a random element in a 1:1 ratio to receive either 4 weekly regular early specialist symptom control care, or standard care. The primary outcome is health related quality of life for patients at 12 weeks. Secondary outcomes include health related quality of life for patients at 24 weeks, carer health related quality of life at 12 and 24 weeks, patient and carer mood at 12 and 24 weeks, overall survival and analysis of healthcare utilisation and cost. DISCUSSION: Current practice in the United Kingdom is to involve specialist palliative care towards the final weeks or months of a life-limiting illness. This study aims to investigate whether early, regular specialist care input can result in significant health related quality of life gains for patients with mesothelioma and if this change in treatment model is cost-effective. The results will be widely applicable to many institutions and patients both in the United Kingdom and internationally. TRIAL REGISTRATION: Current controlled trials ISRCTN18955704. Date ISRCTN assigned: 31 January 2014.


Assuntos
Neoplasias Pulmonares/terapia , Mesotelioma/terapia , Cuidados Paliativos/métodos , Neoplasias Pleurais/terapia , Qualidade de Vida , Encaminhamento e Consulta , Projetos de Pesquisa , Afeto , Cuidadores/psicologia , Protocolos Clínicos , Efeitos Psicossociais da Doença , Análise Custo-Benefício , Custos de Cuidados de Saúde , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Nível de Saúde , Humanos , Neoplasias Pulmonares/complicações , Neoplasias Pulmonares/diagnóstico , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/psicologia , Mesotelioma/complicações , Mesotelioma/diagnóstico , Mesotelioma/economia , Mesotelioma/mortalidade , Mesotelioma/psicologia , Mesotelioma Maligno , Cuidados Paliativos/economia , Neoplasias Pleurais/complicações , Neoplasias Pleurais/diagnóstico , Neoplasias Pleurais/economia , Neoplasias Pleurais/mortalidade , Neoplasias Pleurais/psicologia , Encaminhamento e Consulta/economia , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento , Reino Unido
3.
Int J Occup Med Environ Health ; 15(3): 267-78, 2002.
Artigo em Inglês | MEDLINE | ID: mdl-12462454

RESUMO

The aim of the study was to assess the risk of asbestos-related malignancies among persons with diagnosed asbestosis. The study covered a cohort composed of 907 men and 490 women afflicted by asbestosis, diagnosed is 1970-1997. The follow-up of the cohort continued until 31 December 1999. In all, 421 deaths were registered and causes of death were retrieved for 93.3% of the deceased. A significantly increased mortality was observed both in the male 1300 deaths; SMR = 127; 95%CI: 113-142) and female (121 deaths, SMR = 150; 95%CI: 124-179) cohorts. The elevated number of deaths in the male and female cohorts were noted mainly due to respiratory diseases (men: 42 deaths; SMR = 344; 95%CI: 248-465; women: 20 deaths, SMR = 789; 95%CI: 482-1219) malignant neoplasms (men: 91 deaths, SMR = 146; 95%CI: 118-179; women: 34 deaths, SMR = 159; 95%CI: 110-222), including lung cancer (men: 39 deaths, SMR = 168; 95% CI: 119-230; women: 13 deaths, SMR = 621; 95%CI: 331-1062) and pleural mesothelioma (men: 3 deaths, SMR = 2680; 95%CI: 553-7832; women: 3 deaths, SMR = 7207; 95%CI: 1031-14612). Taking into account a cumulative dose of fibers, it was found that a significantly increased mortality from lung cancer and pleural mesothelioma applied to persons exposed to a dose above 25 f-y/ml. The results indicate that persons with asbestosis are at higher risk of developing malignant neoplasms, especially lung cancer and mesothelioma.


Assuntos
Asbestose/mortalidade , Neoplasias Pulmonares/mortalidade , Mesotelioma/mortalidade , Doenças Profissionais/mortalidade , Neoplasias Pleurais/mortalidade , Adulto , Idoso , Asbestose/complicações , Causas de Morte , Estudos de Coortes , Feminino , Humanos , Neoplasias Pulmonares/complicações , Masculino , Mesotelioma/complicações , Pessoa de Meia-Idade , Doenças Profissionais/complicações , Neoplasias Pleurais/complicações , Polônia/epidemiologia , Medição de Risco , Indenização aos Trabalhadores
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