RESUMEN
The aim of this paper is to describe the emerging role of the palliative care clinical trials nurse in an era of evidence-based practice and increasing clinical trial activity in palliative care settings across Australia. An overview of the current clinical trials work is provided, with a focus on three aspects of clinical trials nursing practice that have significant implications for patients: managing the consent process, integrating clinical trials into multidisciplinary care, and establishing and building the evidence base to inform practice in palliative care settings. Clinical trials roles provide palliative care nurses with an opportunity to contribute to clinical research, help expand palliative care's evidence base, and develop their own research capabilities.
Asunto(s)
Ensayos Clínicos como Asunto , Prestación Integrada de Atención de Salud/organización & administración , Enfermería Basada en la Evidencia , Cuidados Paliativos , HumanosRESUMEN
BACKGROUND: Breathlessness at rest or on minimal exertion despite optimal treatment of underlying cause(s) is distressing and prevalent. Opioids can reduce the intensity of chronic refractory breathlessness and an anxiolytic may be of benefit. This pilot aimed to determine the safety and feasibility of conducting a phase III study on the intensity of breathlessness by adding regular benzodiazepine to low-dose opioid. METHODS: This is a single site, open label phase II study of the addition of regular clonazepam 0.5 mg nocte orally to Kapanol(R) 10 mg (sustained release morphine sulphate) orally mane together with docusate/sennosides in people with modified Medical Research Council Scale ≥2. Breathlessness intensity on day four was the efficacy outcome. Participants could extend for another 10 days if they achieved >15% reduction over their own baseline breathlessness intensity. RESULTS: Eleven people had trial medication (eight males, median age 78 years (68 to 89); all had COPD; median Karnofsky 70 (50 to 80); six were on long-term home oxygen. Ten people completed day four. One person withdrew because of unsteadiness on day four. Five participants reached the 15% reduction, but only three went on to the extension study, all completing without toxicity. CONCLUSION: This study was safe, feasible and there appears to be a group who derive benefits comparable to titrated opioids. Given the widespread use of benzodiazepines for the symptomatic treatment of chronic refractory breathlessness and its poor evidence base, there is justification for a definitive phase III study.