RESUMO
Background: In 2012, 11 standards describing best supportive care (bsc) in clinical trials in advanced cancer were defined through consensus statements. The consensus included 15 key components. Our objective was to analyze whether clinical trials that involved patients with advanced cancer and that included bsc in at least 1 arm met the standards and contained the key components. Methods: We reviewed clinical trials registered in ClinicalTrials.gov, the isrctn (International Standard Randomised Controlled Trial Number) registry, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform for 2012-2018. We selected only phase iii studies in patients with advanced cancer that included bsc in at least 1 arm. We describe the characteristics of the trials, together with the definition and components of bsc. We analyzed how the trials met the standards and adopted the key components of bsc. Results: Of 193 trials retrieved, only 64 met the inclusion criteria; 36 of those trials (56%) had no definition of bsc. Less than 7% of the trials included even 3 of the 8 bsc standards that were defined to be included in the design of trials. Furthermore, trials mentioned only 5 of the 15 key components that the consensus defined to be fundamental, with symptom management appearing in 22% of trials and the other 4 components appearing in less than 8%. Summary: Most clinical trials registered during 2012-2018 that involved patients with cancer and an arm with bsc did not define the bsc concept. Hence, the design of those trials does not meet the consensus recommendations.
Assuntos
Neoplasias/terapia , Ensaios Clínicos como Assunto , Humanos , Sistema de RegistrosRESUMO
Introducción: la calidad de vida (CdV) tiene significados distintos según se adapte al concepto intuitivo, al metodológico o al resultado de un cuestionario. Objetivo: conocer el concepto intuitivo de CdV de los profesionales de Cuidados Paliativos para los pacientes que tratan y para ellos mismos. Conocer si se adapta a los cuestionarios validados. Material y métodos: estudio cualitativo y cuantitativo con profesionales de Cuidados Paliativos. Se planteó en pregunta abierta qué comprendían de manera intuitiva como CdV en enfermos terminales y en sí mismos. Dieron luego una estimación del peso relativo de los dominios y de la influencia de diversos problemas en la CdV. Los resultados se compararon con el perfil del QLQ-C15-PAL. Resultados: los principales componentes de la CdV en los pacientes fueron: control de síntomas, dignidad personal, familia y calidad de la atención. Este perfil no coincide con el del QLQ-C15-PAL. En los profesionales, los dominios más relevantes fueron salud, capacidad para disfrutar, familia y relaciones personales. Conclusiones: el perfil de lo que intuitivamente estiman como CdV los profesionales de Cuidados Paliativos es diferente en los pacientes y en ellos mismos. Este concepto no coincide con el modelo de los cuestionarios específicos de CdV en Cuidados Paliativos
Background: health-related quality of life (QoL) may have different meanings when interpreted intuitively, methodologically, or as the result of a questionnaire. Objective: to know the intuitive QoL concept in palliative care professionals regarding both the patients they treat and themselves, and to determine whether such concept is consistent with the measures provided by validated questionnaires. Material and methods: a mixed qualitative and quantitative study was performed in palliative care professionals. An open question asked about their intuitive understanding of QoL for terminal patients and themselves. They did an estimation of the relative weight of different domains, and the influence of several problems. These results were compared to the profile of the QLQ-C15-PAL questionnaire. Results: the estimated most important component of QoL in patients was symptom control, followed by personal dignity, family support, and quality of care. This profile is divergent from that of QLQ-C15-PAL, which is focused on symptoms and performance status. Regarding the QoL of professionals themselves, the most relevant domains were health, ability to enjoy, family, and personal relations. Conclusions: the intuitive QoL profile estimated by palliative care professionals is different for patients and for themselves. This intuitive concept is not consistent with the model presented by specific QoL questionnaires for palliative-care patients
Assuntos
Humanos , Qualidade de Vida/psicologia , Doente Terminal/psicologia , Cuidados Paliativos , Inquéritos e Questionários , Relações Médico-Paciente , Direito a Morrer , Relações Interpessoais , Relações FamiliaresRESUMO
"Syndrome of recommended patient" is manifested as the presence of numerous unexpected and unusual complications in patients that the treating physician is trying to give a better assistance. Even assuming that a few complications may appear by chance, there are several factors from daily clinical practice that facilitate the presence of such a syndrome, and some of them can be corrected in order to reduce its incidence. All of them come from the change on daily clinical practice on these patients, as if they do not fit for the attention provided for other people. These factors favouring the presence of this syndrome come from: patients' attitude, inefficient use of health resources, absence of an adequate register of clinical data and change in usual clinical practice on interpretation of diagnostic tests as well as in the indication of treatment of these patients. The best way to prevent this "syndrome of recommended patient" is to maintain, even within these patients, an attitude based on solid clinical knowledge and to follow up the same clinical rules accepted for other patients.
Assuntos
Medicina Baseada em Evidências , Doença Iatrogênica , Erros Médicos , HumanosRESUMO
Chemotherapy improves survival and achieves an impressive response rate, and, eventually, a percentage of long-term survivors in small-cell lung cancer. A possible way to a further improvement of these therapeutic outcomes is increasing chemotherapy dose-intensity. However, randomised comparative trials only show a slight improvement of results, with small clinical relevance. Prophylactic use of colony-stimulating factors decrease the incidence of neutropenia and neutropenic fever in comparative studies when an exceedingly myelotoxic chemotherapy regimen is used. And they also permit a little increase in chemotherapy dose-intensity without significant antineoplastic effect and almost no impact in overall survival. Nowadays, the administration of higher doses of chemotherapy in small-cell lung cancer still remains investigational in oncology.
Assuntos
Antineoplásicos/administração & dosagem , Carcinoma de Células Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Transplante de Medula Óssea , HumanosRESUMO
Chemotherapy shows antitumoral activity in several advanced cancers. However, toxicity is frequent and may even overwhelm the clinical benefit of antineoplastic activity. To recommend such a treatment, we need to know the sensibility of cancer to therapy, its toxic effects and the clinical benefit we are looking for, expressed as: symptoms relief or delay in its presentation, improvement in quality of life, increase in overall survival and reduction in tumor volume. We need also to evaluate the performance status and functional status of each patient, its prognosis, the severity of symptoms and its interest to receive any antitumor treatment. According to these parameters we can individualize each therapy to select those patients whose expected benefit from this palliative chemotherapy is higher.
