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

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.