Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]

<p>Abstract</p> <p>Background</p> <p>Although guidelines for the care of the dying patient exist the evidence base to support the guidelines is poor. Some of the factors contributing to this include failure to recruit to trials, protective healthcare professionals and s...

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Main Authors: Finlay Ilora, Johnstone Ros, Russell Ian, Fowell Andrew, Russell Daphne
Format: Article
Language:English
Published: BMC 2004-04-01
Series:BMC Palliative Care
Online Access:http://www.biomedcentral.com/1472-684X/3/1
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author Finlay Ilora
Johnstone Ros
Russell Ian
Fowell Andrew
Russell Daphne
author_facet Finlay Ilora
Johnstone Ros
Russell Ian
Fowell Andrew
Russell Daphne
author_sort Finlay Ilora
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>Although guidelines for the care of the dying patient exist the evidence base to support the guidelines is poor. Some of the factors contributing to this include failure to recruit to trials, protective healthcare professionals and subsequent attrition from trials due to the death of the patients. Recent studies report favourably on the use of cluster randomisation as an appropriate methodology for use in this patient group.</p> <p>Methods/design</p> <p>A feasibility study, exploring two types of randomisation as appropriate methodology for trials involving dying patients. Cluster randomisation and randomised consent will be utilised following a crossover design at two sites, one oncology ward and one Macmillan unit within the Northwest Wales NHS Trust. All patients commencing on the Integrated Care Pathway (ICP) for the Last Days of Life will be eligible for inclusion in the study. Using the hypothesis that it is not necessary to prescribe an anti-emetic medication when setting up a syringe driver for the dying patient, the study will evaluate different models of research methodology.</p> <p>Discussion</p> <p>The identification of the most appropriate methodology for use in studies concerning this patient group will inform the development of future clinical studies. Furthermore, the outcomes of this feasibility study will inform the development, of a proposal seeking funding for Wales-wide trials in palliative care. The identification of an appropriate methodology will provide a starting point for the establishment of a robust evidence base for the care of the dying patient.</p>
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spelling doaj.art-74c38afff99147689c0f5d84eb00daba2022-12-22T02:04:33ZengBMCBMC Palliative Care1472-684X2004-04-0131110.1186/1472-684X-3-1Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]Finlay IloraJohnstone RosRussell IanFowell AndrewRussell Daphne<p>Abstract</p> <p>Background</p> <p>Although guidelines for the care of the dying patient exist the evidence base to support the guidelines is poor. Some of the factors contributing to this include failure to recruit to trials, protective healthcare professionals and subsequent attrition from trials due to the death of the patients. Recent studies report favourably on the use of cluster randomisation as an appropriate methodology for use in this patient group.</p> <p>Methods/design</p> <p>A feasibility study, exploring two types of randomisation as appropriate methodology for trials involving dying patients. Cluster randomisation and randomised consent will be utilised following a crossover design at two sites, one oncology ward and one Macmillan unit within the Northwest Wales NHS Trust. All patients commencing on the Integrated Care Pathway (ICP) for the Last Days of Life will be eligible for inclusion in the study. Using the hypothesis that it is not necessary to prescribe an anti-emetic medication when setting up a syringe driver for the dying patient, the study will evaluate different models of research methodology.</p> <p>Discussion</p> <p>The identification of the most appropriate methodology for use in studies concerning this patient group will inform the development of future clinical studies. Furthermore, the outcomes of this feasibility study will inform the development, of a proposal seeking funding for Wales-wide trials in palliative care. The identification of an appropriate methodology will provide a starting point for the establishment of a robust evidence base for the care of the dying patient.</p>http://www.biomedcentral.com/1472-684X/3/1
spellingShingle Finlay Ilora
Johnstone Ros
Russell Ian
Fowell Andrew
Russell Daphne
Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
BMC Palliative Care
title Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
title_full Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
title_fullStr Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
title_full_unstemmed Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
title_short Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]
title_sort cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care a feasibility study isrctn60243484
url http://www.biomedcentral.com/1472-684X/3/1
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