BMJ  2003;327:198 (26 July), doi:10.1136/bmj.327.7408.198

Paper

Novel consent process for research in dying patients unable to give consent

Elizabeth Rees, research nurse in palliative care1, Janet Hardy, consultant in palliative care1

1 Department of Palliative Medicine, Royal Marsden Hospital, Sutton, Surrey SM2 5PT

Correspondence to: J Hardy

Objectives To develop a process of advance consent to enable research to be undertaken in patients in the terminal phase.

Design Feasibility study of an advance consent process to support a randomised controlled trial of two antimuscarinic drugs (hyoscine hydrobromide and glycopyrronium bromide) in the management of noisy respirations associated with retained secretions ("death rattle").

Setting Palliative care wards in a major cancer centre.

Participants Patients admitted to a palliative care ward who may develop "death rattle" and thus be eligible for randomisation.

Main outcome measures Patient accrual; acceptability of the consent process.

Results Of the 107 patients approached, 58 patients gave advance consent to participate in the study. Of these, 15 patients developed death rattle and were randomised to receive either hyoscine or glycopyrronium; 16 patients died elsewhere; 15 patients died on the palliative care wards but were not randomised; 12 patients are still alive.

Conclusions Initial assessment suggests that this is a workable consent process allowing research to be undertaken in patients who are unable to give consent at the time of randomisation. Patient accrual rates to date are lower than needed to recruit adequate numbers in the time allotted to answer the research question.


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