Quantitative and qualitative analysis of study-related patient information sheets in randomised neuro-oncology phase III-trials.

INTRODUCTION: In randomised controlled trials (RCTs), patient informed consent documents are an essential cornerstone of the study flow. However, these documents are often oversized in format and content. Clinical experience suggests that study information sheets are often not used as an aid to decision-making due to their complexity. MATERIAL AND METHODS: We analysed nine patient informed consent documents from clinical neuro-oncological phase III-studies running at a German Brain Tumour Centre with the objective to investigate the quality of these documents. Text length, formal layout, readability, application of ethical and legal requirements, scientific evidence and social aspects were used as rating categories. Results were assessed quantitatively by two independents investigators and were depicted using net diagrams. RESULTS: All patient informed consent documents were of insufficient quality in all categories except that ethical and legal requirements were fulfilled. Notably, graduate levels were required to read and understand five of nine consent documents. DISCUSSION: Quality deficits were consistent between the individual study information texts. Irrespective of formal aspects, a document that is intended to inform and motivate patients to participate in a study needs to be well-structured and understandable. We therefore strongly mandate to re-design patient informed consent documents in a patient-friendly way. Specifically, standardised components with a scientific foundation should be provided that could be retrieved at various times, adapted to the mode of treatment and the patient's knowledge, and could weigh information dependent of the stage of treatment decision.

Conspiración de silencio y malestar emocional en pacientes diagnósticados de glioblastoma multiforme / No disponible

Objetivo: En el ámbito de enfermedades muy graves y de mal pronóstico, continúa existiendo un importante porcentaje de familiares que, por motivos beneficentes y de protección, deciden ocultar la verdad a los enfermos que desean conocer lo que les ocurre. El objetivo es identificar la incidencia de conspiración de silencio familiar y su repercusión en los niveles de ansiedad y depresión del paciente diagnosticado de glioblastoma multiforme (GBM). Método: Los niveles de ansiedad y depresión fueron recogidos en cinco momentos del proceso de enfermedad: ingreso, después de la comunicación del diagnóstico, en el alta hospitalaria, un mes después del alta y seis meses después del alta. Las necesidades de información fueron recogidas en el momento del ingreso. Resultados: El 19,3 % de las familias, consideró que no sería conveniente comunicar al paciente lo que le ocurría a pesar de que éste quería conocer aspectos relacionados con su enfermedad. Esta conspiración repercute en los niveles de ansiedad del paciente hasta incluso un mes después del alta hospitalaria. En este momento de la enfermedad, en los pacientes donde existía pacto de silencio presentaban unos niveles psicopatológicos de ansiedad (12,71±2,28), mientras que los niveles de ansiedad de los pacientes a los que se les permitió una comunicación abierta estaban por debajo de la significación clínica (7,00±3,27). Conclusiones: Existe una alta incidencia de pacto de silencio en pacientes con GBM y su repercusión sobre el malestar emocional de los enfermos se mantiene durante un largo periodo de tiempo (AU)

Aim: For those patients suffering serious illnesses with a poor prognosis, there continues to be a significant percentage of well-meaning family members who, out of a desire to protect the patient, decide to hide the truth, even if the patient wishes to know what the real situation is. Methods: To measure the incidence of conspiracies of silence within families and their repercussions on levels of anxiety and depression of patients diagnosed Glioblastoma Multiforme (GBM). Findings: 19.3 % of the families taking part thought that it would not be appropriate to give the patient information about their disease, despite the patient stating that he or she would like to know more about their disease. This conspiracy had an impact on the anxiety levels of the patient even a month after the discharge from hospital. At this point in the disease process, those patients where there was a conspiracy of silence demonstrated psychopathological levels of anxiety (12.71±2.28), whereas the levels of anxiety for those patients who were allowed more open communication showed levels which were below clinical significance (7.00±3.27). Conclusions: The needs for information of family members and patients with GBM are different and their repercussions on emotional distress in patients can continue during a prolonged period of time (AU)

Relation of surgery, tumor site, and age group to the loss of reality testing in Japanese patients with malignant tumors: a study of a hospital-based sample with a consultation-liaison service.

The relation between surgery and the loss of reality testing (LRT) in Japanese patients with malignant tumors were examined, taking into account the influence of the tumor sites and age groups. The patients were comprised of 277 men and 225 women with malignant tumors in Kyushu University Hospital, Fukuoka, Japan, who underwent a check-up at the Department of Neuropsychiatry for the first time using the consultation-liaison system. Those with known schizophrenia, dementia, mental retardation, and paranoid or schizoid (schizotypal) personality disorder were excluded. Surgery was statistically significantly associated with LRT in elderly men (> or =65 years of age), and in men with malignant tumors of the digestive organs (odds ratio [OR], 9.7; 95% confidence interval [95% CI], 3.2-29.3). Even after adjusting for tumor site and age, surgery was statistically significantly associated with LRT in men (OR, 2.6; 95% CI, 1.4-4.6) and nearly significantly associated in women (OR, 1.8; 95% CI, 0.9-3.6). There were no material associations between surgery and LRT in patients with malignant tumors of sex-specific organs or the head and neck area. The present study showed a positive relationship between surgery and LRT in Japanese men and women with malignant tumors. The association was stronger in elderly patients. As for tumor site, surgery was most strongly associated with an increased risk of LRT in patients with malignant tumors of the digestive organs.

Neuropsychological outcome in long-term survivors of a childhood extracranial solid tumor who have undergone autologous bone marrow transplantation.

The purpose of this study was to evaluate neuropsychological and adaptive functioning of children who have undergone bone marrow transplantation (BMT) without previous cranial irradiation. In total, 76 children treated for an extracranial tumor with BMT without total body irradiation (TBI) were evaluated at least 5 years after the end of the treatment.Overall, their performance and skills were in the normal range and their professional and academic outcomes were satisfactory. Nevertheless, we observed a deleterious effect of deafness on verbal IQ associated with the previous administration of cisplatin during conventional chemotherapy. In addition, reading difficulties had arisen. This could be related to absence from kindergarten or primary school during hospitalization. Finally, in the younger subgroup, visual-perceptual skills were found to be more fragile.

Neurologic paraneoplastic syndromes.

Several neurologic paraneoplastic disorders are believed to be caused by an autoimmune reaction against antigen(s) co-expressed by tumour cells and neurons. Of the paraneoplastic syndromes, the evidence for an autoimmune etiology is strongest for the Lambert-Eaton myasthenic syndrome, in which autoantibodies downregulate voltage-gated calcium channels at the presynaptic nerve terminal. For other syndromes, including cerebellar degeneration, multifocal encephalomyelitis, sensory neuronopathy, limbic encephalitis, opsoclonus-myoclonus, stiff person syndrome, and retinal degeneration, the autoimmune theory is supported by the presence of specific antineuronal antibodies. These antibodies serve as a useful diagnostic tool, but their actual role in causing neuronal injury and clinical disease remains unclear. Further understanding of immunopathogenesis awaits successful experimental models. Among different syndromes, a varied proportion of patients shows neurologic improvement with immunosuppressive treatments; it is likely that many patients have already suffered irreversible neuronal injury at the time of diagnosis.

Neuropsychological status of children with acute lymphoblastic leukemia treated for central nervous system relapse.

Approximately 10% of children treated with contemporary therapy for acute lymphoblastic leukemia (ALL) will experience an isolated relapse in the central nervous system (CNS). From 5 to 25% of this group will become long-term survivors, but only after additional, more aggressive therapy. A review of the limited number of studies of children surviving treatment for CNS relapse disclosed a strikingly higher incidence of intellectual impairment than was found in similarly treated patients who remain in complete remission. Specific risk factors for this complication included the number of courses of cranial irradiation, a young age at treatment, increasing time since treatment, neuropathological changes apparent on abnormal computed tomography scans of the brain, and seizures. The methodological problems inherent in neurobehavioral research in childhood acute lymphoblastic leukemia are critically reviewed and suggestions for future studies are offered. Children with a CNS relapse should be serially evaluated for psychoeducational performance to facilitate early intervention in cases of learning difficulties.